Cleared Traditional

K911076 - JAIN QUICK COUNT

K911076 is an FDA 510(k) clearance for JAIN QUICK COUNT, manufactured by Jain Surgical Equipment, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K911076 · Jain Surgical Equipment, Inc. · General Hospital
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May 1991
Decision
80d
Days
Class 2
Risk

K911076 is an FDA 510(k) clearance for the JAIN QUICK COUNT. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Jain Surgical Equipment, Inc. (Kalamazoo, US). The FDA issued a Cleared decision on May 30, 1991 after a review of 80 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 Jain Surgical Equipment, Inc. devices

FDA 510(k) Submission Details - K911076

510(k) Number K911076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 11, 1991
Decision Date May 30, 1991
Days to Decision 80 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
49d faster than avg
Panel avg: 129d · This submission: 80d
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 85
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K911076.
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
DISPOSAL PAD FOR SHARPS
K910516 · Visitec Co. · Apr 1991
QUALTEX NEEDLE COUNTERS
K903947 · Deroyal Industries, Inc. · Oct 1990
DISPOSINEEDLE SHARPS DISPOSAL UNIT
K897095 · Specialites Septodont · Jan 1990