510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012121Substantially Equivalent

Secureguard Retractable Safety Syringe

Safegard Medical Products, Inc., Tampa FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012121 is the FDA 510(k) clearance record for SECUREGUARD RETRACTABLE SAFETY SYRINGE, a class II device, cleared for Safegard Medical Products, Inc. on under FDA product code MEG (Syringe, Antistick). FDA records list 2 510(k) clearances for Safegard Medical Products, Inc., from to . As of , FDA records show one recall naming K012121.

Clearance record

Decision date
Received
(110 days to decision)
Product code
MEG Syringe, Antistick
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Safegard Medical Products, Inc. 14802 Hadleigh Way, Tampa FL
510(k) summary
Summary
Third party review
No

Clearances, product code MEG

Trailing 12 months
2 clearances under product code MEG in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code MEG, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20261
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260