Cleared Traditional

K932694 - KAPPLER PRO/VENT PROCEDURE GOWN

K932694 is an FDA 510(k) clearance for KAPPLER PRO/VENT PROCEDURE GOWN, manufactured by Kappler, Inc.. The device is a Class 2 General Hospital device with product code FYA cleared through the Traditional 510(k) pathway after a 299-day FDA review.

K932694 · Kappler, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
299d
Days
Class 2
Risk

K932694 is an FDA 510(k) clearance for the KAPPLER PRO/VENT PROCEDURE GOWN. Classified as Gown, Surgical (product code FYA), Class II - Special Controls.

Submitted by Kappler, Inc. (Guntersville, US). The FDA issued a Cleared decision on March 29, 1994 after a review of 299 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, Inc. devices

FDA 510(k) Submission Details - K932694

510(k) Number K932694 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 03, 1993
Decision Date March 29, 1994
Days to Decision 299 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
170d slower than avg
Panel avg: 129d · This submission: 299d
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 237
Devices cleared under the same product code (FYA) and FDA review panel - the closest regulatory comparables to K932694.
HYDRAGOWN
K934664 · Mallinckrodt Group, Inc. · May 1994
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