Reserved Medical Devices

The following devices are devices that FDA believes meet the reserved criteria in section 206 of the Modernization Act and, therefore, would remain subject to premarket notification under new section 510(l) added to the act:

862.1065	Ammonia test system.
862.1113	Bilirubin (total and unbound) in the neonate test system.
862.1175	Cholesterol (total) test system.
862.1310	Galactose test system.
862.1410	Iron (non-heme) test system.
862.1415	Iron-binding capacity test system.
862.1450	Lactic acid test system.
862.1495	Magnesium test system.
862.1510	Nitrite (nonquantitative) test system.
862.1580	Phosphorus (inorganic) test system.
862.1660	Quality control material (assayed and unassayed). 1
862.1675	Blood specimen collection device.
862.1680	Testosterone test system.
862.1705	Triglyceride test system.
862.1730	Free tyrosine test system.
862.1775	Uric acid test system.
862.2050	General purpose laboratory equipment labeled or promoted for a specific medical use.
862.3050	Breath-alcohol test system.
862.3110	Antimony test system.
862.3120	Arsenic test system.
862.3220	Carbon monoxide test system.
862.3240	Cholinesterase test system.
862.3280	Clinical toxicology control material. 1
862.3600	Mercury test system.
862.3750	Quinine test system.
862.3850	Sulfonamide test system.
864.3250	Specimen transport and storage container. 86
864.7040	Adenosine triphosphate release assay.
864.8950	Russell viper venom reagent.
864.9050	Blood bank supplies.
864.9125	Vacuum-assisted blood collection system. 2
866.2050	Staphylococcal typing bacteriophage.
866.2390	Transport culture medium.
866.2560	Microbial growth monitor.
866.2850	Automated zone reader.
866.2900	Microbiological specimen collection and transport device.
866.3040	Aspergillusspp. serological reagents.
866.3110	Campylobacter fetusserological reagents.
866.3120	Chlamydia serological reagents.
866.3235	Epstein-Barr virus serological reagents.
866.3330	Influenza virus serological reagents.
866.3370	Mycobacterium tuberculosisimmunofluorescent reagents.
866.3400	Parainfluenza virus serological reagents.
866.3480	Respiratory syncytial virus serological reagents.
866.3500	Rickettsia serological reagents.
866.3740	Streptococcusspp. serological reagents.
866.3870	Trypanosomaspp. serological reagents.
868.1100	Arterial blood sampling kit.
868.5240	Anesthesia breathing circuit.
868.5540	Rigid laryngoscope.
868.5770	Tracheal tube fixation device.
868.6810	Tracheobronchial suction catheter. 81
870.4500	Cardiovascular surgical instruments.
872.3240	Dental bur. 90
872.3980	Endosseous dental implant accessories.
872.4200	Dental handpiece and accessories.
872.4535	Dental diamond instrument. 92
872.4565	Dental hand instrument. 93
872.4730	Dental injecting needle. 94
872.5410	Orthodontic appliance and accessories. 95
872.6250	Dental chair and accessories. 18
872.6510	Oral irrigation unit.
872.6640	Dental operative unit and accessories. 21
872.6710	Boiling water sterilizer.
872.6855	Manual toothbrush.
874.4140	Ear, nose, and throat bur.
874.4420	Ear, nose, and throat manual surgical instrument. 24
876.1075	Gastroenterology-urology biopsy instrument. 26
876.4680	Ureteral stone dislodger.
876.5160	Urological clamp for males. 6
876.5540	Blood access device and accessories. 34
878.4014	Nonresorbable gauze/sponge for external use.
878.4200	Introduction/drainage catheter and accessories.
878.4460	Surgeon's glove.
878.4800	Manual surgical instrument for general use.
878.5900	Nonpneumatic tourniquet.
880.5090	Liquid bandage. 8
880.5680	Pediatric position holder.
880.6250	Patient examination glove.
880.6375	Patient lubricant.
880.6760	Protective restraint.
880.6960	Irrigating syringe.
882.1030	Ataxiagraph.
882.1420	Electroencephalogram (EEG) signal spectrum analyzer.
882.4060	Ventricular cannula. 9
882.4190	Clip forming/cutting instrument.
882.4525	Microsurgical instrument.
882.4545	Shunt system implantation instrument. 10
884.1730	Laparoscopic insufflator. 51
884.2980	Telethermographic system.
884.2982	Liquid crystal thermographic system.
884.4520	Obstetric-gynecologic general manual instrument.
884.5435	Unscented menstrual pad. 80
886.1050	Adaptometer (biophotometer).
886.4070	Powered corneal burr. 14
886.4300	Intraocular lens guide. 15
886.4350	Manual ophthalmic surgical instrument.
886.4370	Keratome.
890.3475	Limb orthosis.
890.3850	Mechanical wheelchair.
890.5710	Hot or cold disposable pack. 16
892.1100	Scintillation (gamma) camera.
892.1110	Positron camera.

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Footnotes:

1	Exemption is limited to unassayed material, except when used in conjunction with donor screening tests.
2	Exemption is limited to manual devices.
6	Exemption does not include devices for internal use or devices used for females.
8	Exemption is limited to uses as a skin protectant.
9	Exemption is limited to surgical grade stainless steel.
10	The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory is exempt from the premarket notification procedures .
14	Exemption is limited to rust ring removal.
15	Exemption does not apply if used as folders and injectors for soft or foldable IOL's.
16	Exemption does not apply when indicated for infants.
18	Only chairs without operative unit device are 510(k) exempt. Dental chair with operative unit, product code KLC, requires 510(k) clearance. Dental chair without operative unit, product code NRU, is exempt from 510(k).
21	Only the accessories tray to the unit is 510(k) exempt. Dental operative unit, product code EIA, requires 510(k) clearance. Oral cavity evacuator, product code EHZ , is exempt from 510(k). Saliva ejector mouthpiece, product code DYN , is exempt from 510(k). Suction operatory unit, product code EBR, is exempt from 510(k). Operative dental unit accessories, product code NRD, is exempt from 510(k).
24	510(k) exempt only if the device is made of the same materials that were used in the device before May 28, 1976.
26	Only biopsy forceps cover and the non­electric biopsy forceps are 510(k) exempt.
34	Only the cannula clamp, disconnect forceps, crimp plier, tube plier, crimp ring, and joint ring, accessories for both the implanted and nonimplanted blood access device are 510(k) exempt.
51	Only tubing and tubing/filter kits which include accessory instruments which are not used to effect intra­abdominal access, Verres needles etc.; and single­use tubing kits used for only intra­abdominal insufflation (pneumoperitoneum) are 510(k) exempt.
80	510(k) exempt only when the device is made of common celluosic and synthetic material with an established safety profile. Exemption does not include the intralabial pads and reusable menstrual pads.
81	Device is not exempt from the design control requirements section of the GMP.
86	This section does not apply to specimen transport and storage containers that are intended for use as part of an over-the-counter test sample collection system for drugs of abuse testing.
90	Reprocessed diamond-coated bur, product code NME, requires 510(k) clearance.
92	Reprocessed diamond dental instrument, product code NLD, requires 510(k) clearance. Diamond dental instrument, product code DZP, is 510(k) exempt.
93	If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in §872.9. The following three product codes associated with this regulation require 510(k) clearance. There are 59 product codes associated with this regulation that are exempt from 510(k). Dental lapping tool kit, product code NYG, requires 510(k) clearance. Parallelometer, product code EGI, requires 510(k) clearance. (Dental) irrigating syringe, product code EIB, requires 510(k) clearance.
94	Reprocessed dental needle, product code NMW, requires 510(k) clearance. Dental needle, product code DZM, is exempt from 510(k).
95	Reprocessed orthodontic metal bracket, product code NQS, requires 510(k) clearance. Product codes ECI, DYO, ECM, EJF, ECN, DYJ, ECO, DZD, DZC, are exempt from 510(k).