Cleared Traditional

DISPOSABLE EMISSIONS BARRIER LASER DRAPE (K903346) - FDA 510(k) Clearance

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

K903346 · Wave-Form Systems, Inc. · General Hospital
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Dec 1990
Decision
133d
Days
Class 2
Risk

K903346 is an FDA 510(k) clearance for the DISPOSABLE EMISSIONS BARRIER LASER DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Wave-Form Systems, Inc. (Portland, US). The FDA issued a Cleared decision on December 5, 1990 after a review of 133 days - within the typical 510(k) review window.

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 Wave-Form Systems, Inc. devices

Submission Details

510(k) Number K903346 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 25, 1990
Decision Date December 05, 1990
Days to Decision 133 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
4d slower than avg
Panel avg: 129d · This submission: 133d
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 26
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K903346.
CONVERTORS OPTI-SORB DRAPE MATERIAL
K940702 · Baxter Healthcare Corp · Apr 1994
STERILE CONVERTORS SMS POLYPROPYLENE GOWN & DRAPE
K924101 · Baxter Healthcare Corp · Apr 1994
CONVERTORS SAFECARE GOWN & DRAPE MATERIAL
K913506 · Baxter Healthcare Corp · Oct 1991
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