Cleared Traditional

K953654 - ORS-111

K953654 is an FDA 510(k) clearance for ORS-111, manufactured by O.R. Solutions, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K953654 · O.R. Solutions, Inc. · General Hospital
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Sep 1995
Decision
51d
Days
Class 2
Risk

K953654 is an FDA 510(k) clearance for the ORS-111. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by O.R. Solutions, Inc. (Chantilly, US). The FDA issued a Cleared decision on September 22, 1995 after a review of 51 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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 O.R. Solutions, Inc. devices

FDA 510(k) Submission Details - K953654

510(k) Number K953654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 02, 1995
Decision Date September 22, 1995
Days to Decision 51 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
78d faster than avg
Panel avg: 129d · This submission: 51d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 - KKX Drape, Surgical

All 165
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K953654.
CONVERTORS DRAPE MATERIAL
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SURGICAL DRAPE KIT
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CIVCO PROBE BOOT/CORD COVER
K943393 · CIVCO Medical Instruments Co., Inc. · Feb 1995
CONVERTORS ISO BAC DRAPE MATERIAL
K931267 · Baxter Healthcare Corp · Nov 1994