Cleared Traditional

K902191 - CUSTOMED LAP PACK II

K902191 is an FDA 510(k) clearance for CUSTOMED LAP PACK II, manufactured by Customed, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 168-day FDA review.

K902191 · Customed, Inc. · General Hospital
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Oct 1990
Decision
168d
Days
Class 2
Risk

K902191 is an FDA 510(k) clearance for the CUSTOMED LAP PACK II. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Customed, Inc. (Carolina Puerto Rico, US). The FDA issued a Cleared decision on October 31, 1990 after a review of 168 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 Customed, Inc. devices

FDA 510(k) Submission Details - K902191

510(k) Number K902191 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1990
Decision Date October 31, 1990
Days to Decision 168 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
39d slower than avg
Panel avg: 129d · This submission: 168d
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 202
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K902191.
ORION STERILE OR TOWELS
K903117 · Orion Life Systems, Inc. · Dec 1990
QUALTEX SURGICAL DRAPE
K904960 · Deroyal Industries, Inc. · Dec 1990
CUSTOMED CYSTO PACK II
K901705 · Customed, Inc. · Oct 1990
CUSTOMED BASIC PACK I
K902884 · Customed, Inc. · Sep 1990
CUSTOMED BASIC PACK II
K902885 · Customed, Inc. · Sep 1990
CUSTOMED BASIC PACK III
K902886 · Customed, Inc. · Sep 1990