Home / 510(k) Clearances / K101708

510(k) K101708

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 24, 2011
Date Received
June 17, 2010
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)
  • K081420 — VANISHPOINT I.V. CATHETER (November 7, 2008)
  • K072654 — PATIENT SAFE SYRINGE (December 14, 2007)
  • 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

  • K253068 — Profoject™ Insulin Syringes; Profoject™ Safelock Disposable Insulin Syringe (February 23, 2026)
  • K253769 — Instylla Delivery Kit (December 22, 2025)
  • K252518 — DuoprossTM Smart Cap (Type I) (December 17, 2025)
  • K251089 — EXEL Disposable Syringe; EXEL Disposable Syringe with Needle; EXEL Disposable Sy (December 12, 2025)
  • K250192 — Verisafe Safety Retractable Insulin Syringes (December 10, 2025)
  • K250853 — Merit Syringe (November 4, 2025)
  • K250510 — Sure-Fine Insulin Syringes (October 15, 2025)
  • K243660 — Monoject™ 1mL Tuberculin Syringe Luer-Lock Tip (1180100777); Monoject™ 3mL Syri (August 22, 2025)
  • K251350 — BD Plastipak™ Syringe (July 29, 2025)
  • K252033 — Profoject™ Disposable Syringe, Profoject™ Disposable Syringe with Needle (July 25, 2025)