• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Reserved Medical Devices

  • Print
  • Share
  • E-mail
-

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  
862.1113  
862.1310  
862.1495  
862.1680  
862.1730  
862.1775  
862.3110  
862.3120  
862.3600  
862.3750  
862.3850  
864.8950  
864.9050  
864.9125 2  
866.2390  
866.2560  
866.2850  
866.2900  
866.3110  
866.3120  
866.3235  
866.3370  
866.3870  
872.4200  
872.6250 18  
872.6640 21  
872.6710  
878.4460  
880.5090 8  
880.5680  
880.6250  
880.6375  
882.1030 96  
882.1420  
884.2980  
884.2982  
884.5435 80  
886.4300 15  
886.4370  
890.3850  
890.5710 16  
892.1100  
892.1110  


Footnotes:

2

Exemption is limited to manual devices.

8

Exemption is limited to uses as a skin protectant.

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).

80

510(k) exempt only when the device is made of common celluosic and synthetic material with an established safety profile.

96

Exemption is limited to ataxiagraphs that do not provide an interpretation or a clinical implication of the measurement

-
-