Cleared Traditional

K910516 - DISPOSAL PAD FOR SHARPS

K910516 is an FDA 510(k) clearance for DISPOSAL PAD FOR SHARPS, manufactured by Visitec Co.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 83-day FDA review.

K910516 · Visitec Co. · General Hospital
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Apr 1991
Decision
83d
Days
Class 2
Risk

K910516 is an FDA 510(k) clearance for the DISPOSAL PAD FOR SHARPS. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Visitec Co. (Sarasota, US). The FDA issued a Cleared decision on April 29, 1991 after a review of 83 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 Visitec Co. devices

FDA 510(k) Submission Details - K910516

510(k) Number K910516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 05, 1991
Decision Date April 29, 1991
Days to Decision 83 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
46d faster than avg
Panel avg: 129d · This submission: 83d
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 K910516.
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
QUALTEX NEEDLE COUNTERS
K903947 · Deroyal Industries, Inc. · Oct 1990
PROTECTOR (SURGICAL INSTRUMENT)
K890314 · Richard-Allan Medical Ind., Inc. · Feb 1989
DISPOSABLE NEEDLE COUNTER
K861307 · Anago, Inc. · May 1986