510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K921913Substantially Equivalent

Hypo-Gard

Epi Medical Products, Inc., Canton MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K921913 is the FDA 510(k) clearance record for HYPO-GARD, a class II device, cleared for Epi Medical Products, Inc. on under FDA product code MMK (Container, Sharps). FDA records list one 510(k) clearance for Epi Medical Products, Inc. As of , FDA records show no recalls naming K921913.

Clearance record

Decision date
Received
(92 days to decision)
Product code
MMK Container, Sharps
Regulation
21 CFR 880.5570
Device class
Class II
Review panel
General Hospital
Applicant
Epi Medical Products, Inc. 42040 Koppernick, Canton MI
510(k) summary
Statement
Third party review
No

Clearances, product code MMK

Trailing 12 months
3 clearances under product code MMK 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 MMK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20260
April 20260
May 20261
June 20260
July 20260
August 20261
September 20260
October 20260