Cleared Traditional

K950830 - STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00 (16X10), 100-183-00 W/DEXTER WRAP

K950830 is an FDA 510(k) clearance for STA-PUT NON-MAGNETIC INSTRUMENT DRAPE C..., manufactured by Avail-Southwest Division. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 68-day FDA review.

K950830 · Avail-Southwest Division · General Hospital
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May 1995
Decision
68d
Days
Class 2
Risk

K950830 is an FDA 510(k) clearance for the STA-PUT NON-MAGNETIC INSTRUMENT DRAPE CATALOG #100-187-00 (16X20), 100-186-00.... Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Avail-Southwest Division (Dallas, US). The FDA issued a Cleared decision on May 3, 1995 after a review of 68 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 Avail-Southwest Division devices

FDA 510(k) Submission Details - K950830

510(k) Number K950830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1995
Decision Date May 03, 1995
Days to Decision 68 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
61d faster than avg
Panel avg: 129d · This submission: 68d
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 286
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K950830.
DEROYAL SURGICAL INSTRUMENT DRAPE
K950565 · Deroyal Industries, Inc. · Dec 1995
SURGICAL DRAPE KIT
K933148 · Nobelpharma USA, Inc. · Jun 1995
OREX(R) O.R EQUIPMENT DRAPES
K945755 · Thantex Specialties, Inc. · May 1995
REMINGTON MEDICAL DISPOSABLE FLUORO/EQUIPMENT COVER MODEL RMI8
K946060 · Remington Medical, Inc. · Apr 1995
OREX SURGICAL DRAPES
K944859 · Thantex Specialties, Inc. · Feb 1995
COMPEL SURGICALDRAPES
K944863 · Standard Textile Co., Inc. · Feb 1995