Cleared Traditional

K924055 - N-PAC

K924055 is an FDA 510(k) clearance for N-PAC, manufactured by National Healthcare Linen Service. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 380-day FDA review.

K924055 · National Healthcare Linen Service · General Hospital
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Aug 1993
Decision
380d
Days
Class 2
Risk

K924055 is an FDA 510(k) clearance for the N-PAC. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by National Healthcare Linen Service (Safety Harbor, US). The FDA issued a Cleared decision on August 27, 1993 after a review of 380 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4040 - 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all National Healthcare Linen Service devices

FDA 510(k) Submission Details - K924055

510(k) Number K924055 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received August 12, 1992
Decision Date August 27, 1993
Days to Decision 380 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
251d slower than avg
Panel avg: 129d · This submission: 380d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYA Device Classification - Class 2, Special Controls

Product Code FYA Gown, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4040
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 - FYA Gown, Surgical

All 168
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K924055.
COMPEL SURGICAL GOWNS
K940758 · Standard Textile Co., Inc. · Apr 1994
BARRIER FABRIC 450 SURGICAL GOWN
K934608 · Johnson & Johnson Medical, Inc. · Apr 1994
3M PREVENTION FABRIC SURGICAL GOWN #78XX
K930681 · 3M Health Care, Ltd. · Feb 1994
RS OPTIGUARD GOWN & DRAPE MATERIAL
K925715 · Baxter Healthcare Corp · May 1993
COMPEL XTR
K922753 · Standard Textile Co., Inc. · Mar 1993
COMPEL O AND R
K921889 · Standard Textile Co., Inc. · Feb 1993