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
• Submission Type: 510(k)
• Regulation Number: 880.5570
• Device Class: 2
• Total Product Life Cycle (TPLC): TPLC Product Code Report
• GMP Exempt?: No

Recognized Consensus Standards

• ISO 595-1 First edition 1986-12-15 Reusable all-glass or metal-and-glass syringes for medical use - Part 1: Dimensions
• ISO 595-2 First edition 1987-12-15 Reusable all-glass or metal-and-glass syringes for medical use - Part 2: Design, performance requirements and tests
• ISO 7864 Third edition 1993-05-15 Sterile hypodermic needles for single use
• ISO 7886-3 First edition 2005-03-01 Sterile hypodermic syringes for single use -- Part 3: Auto-disable syringes for fixed-dose immunization
• ISO 8537 Second edition 2007-10-01 Sterile single-use syringes, with or without needle, for insulin
• 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
• ISO 11040-4 Second edition 2007-02-01 Prefilled syringes - Part 4: Glass barrels for injectables
• ISO 11040-5 Third edition 2012-02-15 Prefilled syringes - Part 5: Plunger stoppers for injectables
• ISO 594/1 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 1: General requirements
• ISO 594-2 Second edition 1998-09-01 Conical fittings with a 6% (Luer) taper for syringes, needles and certain other medical equipment - Part 2: Lock fittings
• ISO 9626 First edition 1991-09-01 AMENDMENT 1 2001-06-01 Stainless steel needle tubing for the manufacture of medical devices

Guidance Documents

• Guidance on the Content of Premarket Notification [510(K)] Submissions for Hypodermic Single Lumen Needles
• Guidance on the Content of Premarket Notification [510(K)] Submissions for Piston Syringes
• Neonatal and Neonatal Transport Incubators - Premarket Notifications; Final

Third Party Review

• Eligible for Accredited Persons Program

Accredited Persons

• bsi healthcare
• center for measurement standards of industrial
• dekra certification b.v.
• intertek testing services
• pharmalink technical group, llc
• regulatory technology services, llc
• tuv sud america inc.
• underwriters laboratories, inc.