Cleared Traditional

K934630 - UNIVERSAL VIDEO/LASER ARM DRAPE

K934630 is an FDA 510(k) clearance for UNIVERSAL VIDEO/LASER ARM DRAPE, manufactured by Hydro-Med Products, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 399-day FDA review.

K934630 · Hydro-Med Products, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1994
Decision
399d
Days
Class 2
Risk

K934630 is an FDA 510(k) clearance for the UNIVERSAL VIDEO/LASER ARM DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Hydro-Med Products, Inc. (Dallas, US). The FDA issued a Cleared decision on October 28, 1994 after a review of 399 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - 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: 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 Hydro-Med Products, Inc. devices

FDA 510(k) Submission Details - K934630

510(k) Number K934630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1993
Decision Date October 28, 1994
Days to Decision 399 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
270d slower than avg
Panel avg: 129d · This submission: 399d
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 167
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K934630.
SURGICAL DRAPE KIT
K933148 · Nobelpharma USA, Inc. · Jun 1995
CIVCO PROBE BOOT/CORD COVER
K943393 · CIVCO Medical Instruments Co., Inc. · Feb 1995
CONVERTORS ISO BAC DRAPE MATERIAL
K931267 · Baxter Healthcare Corp · Nov 1994
SURGICAL DRAPES
K943122 · Mallinckrodt Group, Inc. · Sep 1994
GLOBAL SHOULDER O.R. DRAPE PACK
K941233 · Depuy, Inc. · Jul 1994
MEDSURG STERILE O.R. TOWELS
K940175 · Medsurg Industries, Inc. · May 1994