Cleared Traditional

SURGICAL 'LASER' DRAPE (K884231) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
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.

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 449
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K884231.
BeneHold™ Surgical Incise Drape with CHG antimicrobial II
K230645 · Avery Dennison Medical , Ltd. · Oct 2023
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
K222578 · 3M Company · May 2023
BeneHold Surgical Incise Drape with CHG antimicrobial
K202208 · Avery Dennison Belgie Bvba · Jul 2021
ControlRad Sterile Cover
K200238 · Controlrad, Inc. · Apr 2020
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833 · Medline Industries, Inc. · Feb 2006
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · Medline Industries, Inc. · Mar 2005