Cleared Traditional

K822735 - SURE-COUNT DISPOSABLE NEEDLE COUNTER

K822735 is the FDA 510(k) clearance for SURE-COUNT DISPOSABLE NEEDLE COUNTER by Geneva Laboratories, Inc.. It is a Class 2 General Hospital device (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

Submission Details

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.

Device Classification

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 33
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
PROTECTOR II
K790661 · Richard-Allan Medical Ind., Inc. · Apr 1979
COUNTER, DISPOSABLE SURGICAL NEEDLE
K790039 · Anago, Inc. · Jan 1979
BOARD, DISPOSABLE CONTROL COUNT
K781791 · Dexide, Inc. · Nov 1978