Cleared Traditional

K936210 - NPAC

K936210 is an FDA 510(k) clearance for NPAC, manufactured by National Healthcare Linen Service. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K936210 · National Healthcare Linen Service · General Hospital
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Feb 1994
Decision
36d
Days
Class 2
Risk

K936210 is an FDA 510(k) clearance for the NPAC. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by National Healthcare Linen Service (St. Petersburg, US). The FDA issued a Cleared decision on February 3, 1994 after a review of 36 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 National Healthcare Linen Service devices

FDA 510(k) Submission Details - K936210

510(k) Number K936210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 1993
Decision Date February 03, 1994
Days to Decision 36 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
93d faster than avg
Panel avg: 129d · This submission: 36d
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 192
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K936210.
STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
K924101 · Baxter Healthcare Corp · Apr 1994
STSTORZ DP5300 AND DP9502 STERILE DRAPES
K934445 · Storz Instrument Co. · Apr 1994
CONTAIN-OR
K934215 · Dlp, Inc. · Feb 1994
VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL
K920346 · Trinity Laboratories, Inc. · Mar 1993
COMPEL SURGICAL DRAPES
K923811 · Standard Textile Co., Inc. · Feb 1993
DRAPE UTILITY/SURGICAL STERILE DISPOSABLE
K920284 · Trinity Laboratories, Inc. · Oct 1992