Cleared Traditional

K822735 - SURE-COUNT DISPOSABLE NEEDLE COUNTER

K822735 is an FDA 510(k) clearance for SURE-COUNT DISPOSABLE NEEDLE COUNTER, manufactured by Geneva Laboratories, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 181-day FDA review.

K822735 · Geneva Laboratories, Inc. · General Hospital
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Mar 1983
Decision
181d
Days
Class 2
Risk

K822735 is an FDA 510(k) clearance for the SURE-COUNT DISPOSABLE NEEDLE COUNTER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Geneva Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on March 9, 1983 after a review of 181 days - an extended review 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: 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 Geneva Laboratories, Inc. devices

FDA 510(k) Submission Details - K822735

510(k) Number K822735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1982
Decision Date March 09, 1983
Days to Decision 181 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d slower than avg
Panel avg: 129d · This submission: 181d
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 80
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K822735.
DISPOSABLE NEEDLE COUNTER (20-530)
K861317 · Anago, Inc. · May 1986
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
SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER
K821394 · Kleen Test Products · Jun 1982
NEEDLE COUNTER-SURE COUNT/100 COUNT
K801259 · Kleen Test Products · Jun 1980