Cleared Traditional

K861307 - DISPOSABLE NEEDLE COUNTER

K861307 is an FDA 510(k) clearance for DISPOSABLE NEEDLE COUNTER, manufactured by Anago, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 24-day FDA review.

K861307 · Anago, Inc. · General Hospital
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May 1986
Decision
24d
Days
Class 2
Risk

K861307 is an FDA 510(k) clearance for the DISPOSABLE NEEDLE COUNTER. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Anago, Inc. (Fort Worth, US). The FDA issued a Cleared decision on May 2, 1986 after a review of 24 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 Anago, Inc. devices

FDA 510(k) Submission Details - K861307

510(k) Number K861307 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 08, 1986
Decision Date May 02, 1986
Days to Decision 24 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
105d faster than avg
Panel avg: 129d · This submission: 24d
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 39
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K861307.
DISPOSAL PAD FOR SHARPS
K910516 · Visitec Co. · Apr 1991
QUALTEX NEEDLE COUNTERS
K903947 · Deroyal Industries, Inc. · Oct 1990
PROTECTOR (SURGICAL INSTRUMENT)
K890314 · Richard-Allan Medical Ind., Inc. · Feb 1989
DISPOSABLE NEEDLE COUNTER (20-240)
K861316 · Anago, Inc. · May 1986
DISPOSABLE NEEDLE COUNTER (20-530)
K861317 · Anago, Inc. · May 1986
DISPOSABLE NEEDLE COUNTER (20-560)
K861319 · Anago, Inc. · May 1986