Product Classification

• Device: needle, hypodermic, single lumen
• Regulation Description: Hypodermic single lumen needle.
• Regulation Medical Specialty: General Hospital
• Review Panel: General Hospital
• Product Code: FMI
• Premarket Review: Drug Delivery and General Hospital Devices, and Human Factors (DHT3C); Drug Delivery and General Hospital Devices, and Human Factors (DHT3C)
• Submission Type: 510(k)
• Regulation Number: 880.5570
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No
• Summary Malfunction Reporting: Ineligible
• Implanted Device?: No
• Life-Sustain/Support Device?: No

Recognized Consensus Standards

• 5-133 ISO 80369-7 Second edition 2021-05
  Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular or hypodermic applications
• 6-273 ISO 23908 First edition 2011-06-11
  Sharps injury protection - Requirements and test methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling
• 6-278 ISO 11040-5 Third edition 2012-02-15
  Prefilled syringes - Part 5: Plunger stoppers for injectables
• 6-364 ISO 8537 Third edition 2016-03-15
  Sterile single-use syringes, with or without needle, for insulin
• 6-379 ISO 7864 Fourth edition 2016-08-01
  Sterile hypodermic needles for single use - Requirements and test methods
• 6-380 ISO 9626 Second edition 2016-08-01
  Stainless steel needle tubing for the manufacture of medical devices - Requirements and test methods
• 6-381 ISO 6009 Fourth edition 2016-08-01
  Hypodermic needles for single use - Colour coding for identification.
• 6-400 ASTM F3212-16(2023)
  Standard Test Method for Coring Testing of Huber Needles
• 6-441 ISO 7886-3 Second edition 2020-05
  Sterile hypodermic syringes for single use - Part 3: Auto-disabled syringes for fixed-dose immunization
• 6-464 ISO 11040-4 Third edition 2015-04-01
  Prefilled syringes - Part 4: Glass barrels for injectables and sterilized subassembled syringes ready for filling [Including AMENDMENT 1 (2020)]

Third Party Review

• Eligible for 510(k) Third Party Review Program

Accredited Persons

• aabb
• center for measurement standards of industrial
• global quality and regulatory services
• regulatory technology services, llc
• third party review group, llc