510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K896086Substantially Equivalent

Proguard Ii(tm)

Safety-Ject, Inc., Costa Mesa CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K896086 is the FDA 510(k) clearance record for PROGUARD II(TM), a class II device, cleared for Safety-Ject, Inc. on under FDA product code FMF (Syringe, Piston). FDA records list 2 510(k) clearances for Safety-Ject, Inc., from to . As of , FDA records show no recalls naming K896086.

Clearance record

Decision date
Received
(97 days to decision)
Product code
FMF Syringe, Piston
Regulation
21 CFR 880.5860
Device class
Class II
Review panel
General Hospital
Applicant
Safety-Ject, Inc. 535 Anton, Suite 450, Costa Mesa CA
Third party review
No

Clearances, product code FMF

Trailing 12 months
14 clearances under product code FMF in the twelve months to October 2026, December 2025 the highest month at 4.
Show the numbers
Monthly 510(k) clearances under FDA product code FMF, trailing twelve months
MonthClearances
November 20251
December 20254
January 20260
February 20261
March 20260
April 20261
May 20261
June 20262
July 20261
August 20263
September 20260
October 20260