Cleared Traditional

K932253 - ARTHROBOT BI-FOLD DRAPE

K932253 is an FDA 510(k) clearance for ARTHROBOT BI-FOLD DRAPE, manufactured by Andronic Devices, Ltd.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 269-day FDA review.

K932253 · Andronic Devices, Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
269d
Days
Class 2
Risk

K932253 is an FDA 510(k) clearance for the ARTHROBOT BI-FOLD DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Andronic Devices, Ltd. (Richmond,B.C. V6v-2j2, CA). The FDA issued a Cleared decision on February 3, 1994 after a review of 269 days - an extended review cycle.

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. 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 Andronic Devices, Ltd. devices

FDA 510(k) Submission Details - K932253

510(k) Number K932253 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 10, 1993
Decision Date February 03, 1994
Days to Decision 269 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
140d slower than avg
Panel avg: 129d · This submission: 269d
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 268
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K932253.
STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
K924101 · Baxter Healthcare Corp · Apr 1994
STSTORZ DP5300 AND DP9502 STERILE DRAPES
K934445 · Storz Instrument Co. · Apr 1994
CONTAIN-OR
K934215 · Dlp, Inc. · Feb 1994
VARIOUS UTILITY/SURGICAL DRAPE, STERILE, DISPOSABL
K920346 · Trinity Laboratories, Inc. · Mar 1993
COMPEL SURGICAL DRAPES
K923811 · Standard Textile Co., Inc. · Feb 1993
DRAPE UTILITY/SURGICAL STERILE DISPOSABLE
K920284 · Trinity Laboratories, Inc. · Oct 1992