Cleared Traditional

K810208 - BLADE SAFE

K810208 is an FDA 510(k) clearance for BLADE SAFE, manufactured by Instranetics, Inc.. The device is a Class 2 General Hospital device with product code MMK cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K810208 · Instranetics, Inc. · General Hospital
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Feb 1981
Decision
17d
Days
Class 2
Risk

K810208 is an FDA 510(k) clearance for the BLADE SAFE. Classified as Container, Sharps (product code MMK), Class II - Special Controls.

Submitted by Instranetics, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 12, 1981 after a review of 17 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 Instranetics, Inc. devices

FDA 510(k) Submission Details - K810208

510(k) Number K810208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1981
Decision Date February 12, 1981
Days to Decision 17 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
112d faster than avg
Panel avg: 129d · This submission: 17d
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 K810208.
SHARP COLLECTION SYSTEM-SHARP-A-GATOR
K844654 · Devon Industries, Inc. · Dec 1984
NEEDELET HANDLER FOR SHARPS
K830275 · Ritmed, Inc. · Mar 1983
SUTURE-SAFE 40 ADHESIVE NEEDLE COUNTER
K821394 · Kleen Test Products · Jun 1982
NEEDLE COUNTER-SURE COUNT/100 COUNT
K801259 · Kleen Test Products · Jun 1980
PROTECTOR II
K790661 · Richard-Allan Medical Ind., Inc. · Apr 1979
COUNTER, DISPOSABLE SURGICAL NEEDLE
K790039 · Anago, Inc. · Jan 1979