Cleared Traditional

K992445 - MED-GUARD SURGEON'S GOWN

K992445 is an FDA 510(k) clearance for MED-GUARD SURGEON'S GOWN, manufactured by Kappler USA. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 211-day FDA review.

K992445 · Kappler USA · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2000
Decision
211d
Days
Class 2
Risk

K992445 is an FDA 510(k) clearance for the MED-GUARD SURGEON'S GOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Kappler USA (Guntersville, US). The FDA issued a Cleared decision on February 18, 2000 after a review of 211 days - an extended review cycle.

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. Standard predicate reliance. 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 Kappler USA devices

FDA 510(k) Submission Details - K992445

510(k) Number K992445 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 22, 1999
Decision Date February 18, 2000
Days to Decision 211 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 129d · This submission: 211d
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 210
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K992445.
MEDLINE BLOCKADE OR RESISTAT SURGICAL GOWNS AND SURGGICAL DRAPES
K003755 · Medline Industries, Inc. · Feb 2001
MODIFICATION TO CONVERTORS SURGICAL GOWNS
K001189 · Allegiance Healthcare Corp. · Apr 2000
MEDLINE BREATHABLE, IMPERVIOUS DISPOSABLE SURGICAL GOWNS
K993170 · Medline Industries, Inc. · Mar 2000
CONVERTORS SURGICAL GOWNS, STERILE
K994244 · Allegiance Healthcare Corp. · Feb 2000
GOWN BACK, MODEL 13-403N
K992436 · Techstyles · Jan 2000
STRYKER T4 POWER PACK, STRYKER T4 EIGHT STATION BATTERY CHARGER, STRYKER T4 CHARGER MODULE
K994053 · Stryker Instruments · Dec 1999