Cleared Traditional

K911520 - ARTHROBOT(TM) 75 (190 CM) GENERAL PURPO...

K911520 is the FDA 510(k) clearance for ARTHROBOT(TM) 75 (190 CM) GENERAL PURPO... by Andronic Devices, Ltd.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K911520 · Andronic Devices, Ltd. · General Hospital
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Aug 1991
Decision
120d
Days
Class 2
Risk

K911520 is an FDA 510(k) clearance for the ARTHROBOT(TM) 75 (190 CM) GENERAL PURPOSE 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 August 2, 1991 after a review of 120 days - within the typical 510(k) review window.

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

Submission Details

510(k) Number K911520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1991
Decision Date August 02, 1991
Days to Decision 120 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
9d faster than avg
Panel avg: 129d · This submission: 120d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 154
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K911520.
QUALTEX MAGNETIC INSTRUMENT DRAPE
K914369 · Deroyal Industries, Inc. · Dec 1991
CONVERTORS SAFECARE GOWN & DRAPE MATERIAL
K913506 · Baxter Healthcare Corp · Oct 1991
CUSTOM PROCEDURE TRAY
K911565 · Vanguard Medical Concepts, Inc. · Aug 1991
QUALTEX SURGICAL DRAPE
K910495 · Deroyal Industries, Inc. · Feb 1991
CUSTOMED CARDIOVASCULAR PACK
K904693 · Customed, Inc. · Jan 1991
CUSTOMED ANGIODRAPE PACK FEMORAL
K904694 · Customed, Inc. · Jan 1991