Cleared Traditional

K882643 - AM TM SYRGICAL DRAPES

K882643 is an FDA 510(k) clearance for AM TM SYRGICAL DRAPES, manufactured by Henley Intl.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K882643

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.

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 265
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K882643.
THERMALAP
K893212 · O.R. Concepts, Inc. · Jun 1989
SURGICAL 'LASER' DRAPE
K884231 · Henley Intl. · Apr 1989
O.R. TOWELS (STERILE)
K890709 · Cypress Medical Products, Ltd. · Mar 1989
PMS ANGIO DRAPE
K890471 · Professional Medical Services · Feb 1989
3M BRAND LASER PROTECTION SURGICAL DRAPES, 88XX
K874086 · 3M Company · Dec 1987
LASER RESISTANT DRAPE
K873141 · Baxter Healthcare Corp · Oct 1987