Cleared Traditional

K884231 - SURGICAL 'LASER' DRAPE

K884231 is an FDA 510(k) clearance for SURGICAL 'LASER' DRAPE, 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 195-day FDA review.

K884231 · Henley Intl. · General Hospital
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Apr 1989
Decision
195d
Days
Class 2
Risk

K884231 is an FDA 510(k) clearance for the SURGICAL 'LASER' DRAPE. 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 April 20, 1989 after a review of 195 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 - K884231

510(k) Number K884231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 1988
Decision Date April 20, 1989
Days to Decision 195 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
66d slower than avg
Panel avg: 129d · This submission: 195d
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 K884231.
MERCY HIP/KNEE PACK
K896215 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
OR TOWEL PACKS
K894764 · Advance Medical Designs, Inc. · Aug 1989
THERMALAP
K893212 · O.R. Concepts, Inc. · Jun 1989
O.R. TOWELS (STERILE)
K890709 · Cypress Medical Products, Ltd. · Mar 1989
AM TM SYRGICAL DRAPES
K882643 · Henley Intl. · Mar 1989
PMS ANGIO DRAPE
K890471 · Professional Medical Services · Feb 1989