Cleared Traditional

K897095 - DISPOSINEEDLE SHARPS DISPOSAL UNIT

K897095 is the FDA 510(k) clearance for DISPOSINEEDLE SHARPS DISPOSAL UNIT by Specialites Septodont. It is a Class 2 General Hospital device (product code MMK) cleared through the Traditional 510(k) pathway after a 27-day FDA review.

K897095 · Specialites Septodont · General Hospital
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Jan 1990
Decision
27d
Days
Class 2
Risk

K897095 is an FDA 510(k) clearance for the DISPOSINEEDLE SHARPS DISPOSAL UNIT. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Specialites Septodont (Washington, US). The FDA issued a Cleared decision on January 17, 1990 after a review of 27 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 Specialites Septodont devices

Submission Details

510(k) Number K897095 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1989
Decision Date January 17, 1990
Days to Decision 27 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
102d faster than avg
Panel avg: 129d · This submission: 27d
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 40
Devices cleared under the same product code (MMK) and FDA review panel - the closest regulatory comparables to K897095.
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
PROTECTOR (SURGICAL INSTRUMENT)
K890314 · Richard-Allan Medical Ind., Inc. · Feb 1989
DISPOSABLE NEEDLE COUNTER
K861307 · Anago, Inc. · May 1986
DISPOSABLE NEEDLE COUNTER (20-240)
K861316 · Anago, Inc. · May 1986