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510(k) K072654

PATIENT SAFE SYRINGE by Retractable Technologies, Inc. — Product Code FMF

K072654 is an FDA 510(k) premarket notification submitted by Retractable Technologies, Inc. for the device "PATIENT SAFE SYRINGE". The FDA issued a decision of Substantially Equivalent on December 14, 2007. The device falls under product code FMF (Syringe, Piston), a Class II device regulated under 21 CFR 880.5860. Retractable Technologies, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 14, 2007
Date Received
September 20, 2007
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Syringe, Piston
Device Class
Class II
Regulation Number
880.5860
Review Panel
HO
Submission Type

Other clearances by Retractable Technologies, Inc.

  • K202325 — EasyPoint Blood Collection Plus (April 9, 2021)
  • K133635 — EASYPOINT NEEDLE (June 17, 2014)
  • K122355 — VANISHPOINT BLOOD COLLECTION SET (August 23, 2013)
  • K112512 — VANISHPOINT BLOOD COLLECTION SET (October 20, 2011)
  • K101708 — PATIENT SAFE LUER CAP (February 24, 2011)
  • K081420 — VANISHPOINT I.V. CATHETER (November 7, 2008)
  • K051355 — VANISHPOINT I.V. CATHETER (September 23, 2005)
  • K980069 — VANISHPOINT SYRINGE (February 12, 1998)
  • K973301 — ANTI-STICK SYRINGE WITH INTEGRAL HYPODERMIC NEEDLE/VANISHPOINT SYRINGE (November 7, 1997)
  • K971763 — BLOOD COLLECTION TUBE HOLDER VANISHPOINT TUBE HOLDER/SMALL TUBE ADAPTER (August 26, 1997)

Other clearances for product code FMF

  • K262581 — GraftGun Universal Graft Delivery System (GDS®) (August 26, 2026)
  • K252184 — SOL-M Luer Lock Syringe with Exchangeable Needle Tray (August 25, 2026)
  • K253747 — Disposable Pen Injector (KXYC-03C02, KXYC-03A03) (August 14, 2026)
  • K260208 — Ultra-Fine™ SAFETY Insulin Syringe (July 13, 2026)
  • K253110 — Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe (June 18, 2026)
  • K260514 — Profoject™ Safety Needle; Profoject™ Syringe with Safety Needle; Profoject™ Low (June 12, 2026)
  • K253112 — Sofjec (Single use Needle); Sofjec (Single use Syringe with or without Needle); (May 21, 2026)
  • K252279 — Sterile Hypodermic Syringe for Single Use (20ml, 30ml, 50ml, 60ml) (April 17, 2026)
  • K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (February 23, 2026)
  • K253769 — Instylla Delivery Kit (December 22, 2025)

FDA data resources