Cleared Traditional

K821394 - SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER

K821394 is an FDA 510(k) clearance for SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER, manufactured by Kleen Test Products. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K821394 · Kleen Test Products · General Hospital
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Jun 1982
Decision
23d
Days
Class 2
Risk

K821394 is an FDA 510(k) clearance for the SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Kleen Test Products (Mchenry, US). The FDA issued a Cleared decision on June 3, 1982 after a review of 23 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Kleen Test Products devices

FDA 510(k) Submission Details - K821394

510(k) Number K821394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 1982
Decision Date June 03, 1982
Days to Decision 23 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
106d faster than avg
Panel avg: 129d · This submission: 23d
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 48
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K821394.
DISPOSABLE NEEDLE COUNTER (20-560)
K861319 · Anago, Inc. · May 1986
SHARP COLLECTION SYSTEM-SHARP-A-GATOR
K844654 · Devon Industries, Inc. · Dec 1984
NEEDELET HANDLER FOR SHARPS
K830275 · Ritmed, Inc. · Mar 1983
NEEDLE COUNTER-SURE COUNT/100 COUNT
K801259 · Kleen Test Products · Jun 1980
PROTECTOR II
K790661 · Richard-Allan Medical Ind., Inc. · Apr 1979
COUNTER, DISPOSABLE SURGICAL NEEDLE
K790039 · Anago, Inc. · Jan 1979