Cleared Traditional

K882643 - AM TM SYRGICAL DRAPES

K882643 is the FDA 510(k) clearance for AM TM SYRGICAL DRAPES by Henley Intl.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 249-day FDA review.

K882643 · Henley Intl. · General Hospital
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Mar 1989
Decision
249d
Days
Class 2
Risk

K882643 is an FDA 510(k) clearance for the AM TM SYRGICAL DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Henley Intl. (Sugar Land, US). The FDA issued a Cleared decision on March 3, 1989 after a review of 249 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 Henley Intl. devices

Submission Details

510(k) Number K882643 FDA.gov
FDA Decision Cleared Substantially Equivalent - NSE Converted (SN)
Date Received June 27, 1988
Decision Date March 03, 1989
Days to Decision 249 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
120d slower than avg
Panel avg: 129d · This submission: 249d
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 149
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K882643.
CUSTOMED LAP PACK IV
K902031 · Customed, Inc. · Jul 1990
THERMALAP
K893212 · O.R. Concepts, Inc. · Jun 1989
SURGICAL 'LASER' DRAPE
K884231 · Henley Intl. · Apr 1989
3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX
K874086 · 3M Company · Dec 1987
LASER RESISTANT DRAPE
K873141 · Baxter Healthcare Corp · Oct 1987
OPSITE SPECIALITY DRAPES
K872757 · Smith & Nephew, Inc. · Jul 1987