Cleared Traditional

K921913 - HYPO-GARD

K921913 is an FDA 510(k) clearance for HYPO-GARD, manufactured by Epi Medical Products, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 92-day FDA review.

K921913 · Epi Medical Products, Inc. · General Hospital
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Jul 1992
Decision
92d
Days
Class 2
Risk

K921913 is an FDA 510(k) clearance for the HYPO-GARD. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Epi Medical Products, Inc. (Canton, US). The FDA issued a Cleared decision on July 24, 1992 after a review of 92 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5570 - the FDA general hospital device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Epi Medical Products, Inc. devices

FDA 510(k) Submission Details - K921913

510(k) Number K921913 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1992
Decision Date July 24, 1992
Days to Decision 92 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
37d faster than avg
Panel avg: 129d · This submission: 92d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MMK Device Classification - Class 2, Special Controls

Product Code MMK Container, Sharps
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - MMK Container, Sharps

All 87
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K921913.
PHLEBOTOMY SHARPS DISPOSAL CONTAINERS
K943660 · Sage Products, Inc. · Mar 1995
THE SHARPS COLLECTION AND DISPOSAL SYSTEM
K945197 · Devon Industries, Inc. · Dec 1994
IN-ROOM AND SHARPSTAR
K941991 · Sage Products, Inc. · Aug 1994
ICAN NEEDLE COUNTERS
K913446 · Icn Pharmaceuticals, Inc. · Sep 1991
DISPOSAL PAD FOR SHARPS
K910516 · Visitec Co. · Apr 1991
QUALTEX NEEDLE COUNTERS
K903947 · Deroyal Industries, Inc. · Oct 1990