Cleared Traditional

SENGEWALD CATALOG NUMBER 55 66 01 (K863323) - FDA 510(k) Clearance

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

K863323 · Sengewald/USA, Inc. · General Hospital
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Oct 1986
Decision
63d
Days
Class 2
Risk

K863323 is an FDA 510(k) clearance for the SENGEWALD CATALOG NUMBER 55 66 01. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Sengewald/USA, Inc. (Chicago, US). The FDA issued a Cleared decision on October 29, 1986 after a review of 63 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sengewald/USA, Inc. devices

Submission Details

510(k) Number K863323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 27, 1986
Decision Date October 29, 1986
Days to Decision 63 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 faster than avg
Panel avg: 129d · This submission: 63d
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 29
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K863323.
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
ABCO DRAPES/TOWELS
K851314 · Abco Dealers, Inc. · May 1985
GORE-TEX BARRIER SURG. DRAPES & GOWNS
K822641 · W.L. Gore & Associates, Inc. · Jan 1983
STERILE ADHERENT DRAPES
K812809 · Abco Dealers, Inc. · Nov 1981