Cleared Traditional

K896215 - MERCY HIP/KNEE PACK

K896215 is an FDA 510(k) clearance for MERCY HIP/KNEE PACK, manufactured by Westmark, Sterile Packing Systems, Inc. (Sps). The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 110-day FDA review.

K896215 · Westmark, Sterile Packing Systems, Inc. (Sps) · General Hospital
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Feb 1990
Decision
110d
Days
Class 2
Risk

K896215 is an FDA 510(k) clearance for the MERCY HIP/KNEE PACK. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on February 13, 1990 after a review of 110 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.

FDA 510(k) Submission Details - K896215

510(k) Number K896215 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 26, 1989
Decision Date February 13, 1990
Days to Decision 110 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
19d faster than avg
Panel avg: 129d · This submission: 110d
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 351
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K896215.
CUSTOMED LAP PACK IV
K902031 · Customed, Inc. · Jul 1990
ABSORBABLE GAUZE DRAPE
K901465 · Ulti-Med Intl., Inc. · Jun 1990
LAMIN-ADD ADHESIVE SURGICAL DRAPE & CATH. DRESSING
K900945 · Palex Medical, Inc. · May 1990
EQUIP COVERS, STERILE
K897120 · Amedic USA · Jan 1990
STERILE SURGICAL DRAPES AND SHEETS
K896367 · Clinitech, Inc. · Dec 1989
UNDER BUTTOCKS DRAPE
K895404 · Medical Plastics, Inc. · Oct 1989
K896215 · MERCY HIP/KNEE PACK
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