Cleared Traditional

K902030 - CUSTOMED LAP PACK III

K902030 is an FDA 510(k) clearance for CUSTOMED LAP PACK III, 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 69-day FDA review.

K902030 · Customed, Inc. · General Hospital
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Jul 1990
Decision
69d
Days
Class 2
Risk

K902030 is an FDA 510(k) clearance for the CUSTOMED LAP PACK III. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Customed, Inc. (Fajardo, US). The FDA issued a Cleared decision on July 12, 1990 after a review of 69 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Customed, Inc. devices

FDA 510(k) Submission Details - K902030

510(k) Number K902030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1990
Decision Date July 12, 1990
Days to Decision 69 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
60d faster than avg
Panel avg: 129d · This submission: 69d
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 K902030.
CUSTOMED BASIC PACK II
K902885 · Customed, Inc. · Sep 1990
CUSTOMED BASIC PACK III
K902886 · Customed, Inc. · Sep 1990
CUSTOMED LAP PACK I
K902029 · Customed, Inc. · Jul 1990
CUSTOMED LAP PACK IV
K902031 · Customed, Inc. · Jul 1990
ABSORBABLE GAUZE DRAPE
K901465 · Ulti-Med Intl., Inc. · Jun 1990
MERCY HIP/KNEE PACK
K896215 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990