Cleared Traditional

N-PAC (K924055) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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.

Device Classification

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 104
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K924055.
DEPUY STERILE VIEW BARRIER HOOD/GOWN WITH HYTREL
K961239 · Depuy, Inc. · Sep 1996
INTERWOVEN(TM) REUSABLE SURGICAL GOWN
K945658 · Baxter Healthcare Corp · Mar 1995
INTERWOVEN OPTIGUARD REUSABLE GOWN MATERIAL
K944138 · Baxter Healthcare Corp · Dec 1994
RS OPTIGUARD GOWN & DRAPE MATERIAL
K925715 · Baxter Healthcare Corp · May 1993
STERILE CONVERTOR SAFECARE GOWN AND DRAPE
K920837 · Baxter Healthcare Corp · May 1992
STERILE VIEW DISP. HOOD/GOWN UV, BARRIER HOOD, UV
K901536 · Depuy, Inc. · Nov 1990