Cleared Traditional

K812448 - UNI-THANE

K812448 is an FDA 510(k) clearance for UNI-THANE, manufactured by Unicare Systems, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K812448 · Unicare Systems, Inc. · General Hospital
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Oct 1981
Decision
35d
Days
Class 2
Risk

K812448 is an FDA 510(k) clearance for the UNI-THANE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Unicare Systems, Inc. (Mchenry, US). The FDA issued a Cleared decision on October 2, 1981 after a review of 35 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 Unicare Systems, Inc. devices

FDA 510(k) Submission Details - K812448

510(k) Number K812448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 28, 1981
Decision Date October 02, 1981
Days to Decision 35 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
94d faster than avg
Panel avg: 129d · This submission: 35d
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 295
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K812448.
BOUNDARY SURGICAL DRAPE
K812962 · The Buckeye Cellulose Corp. · Nov 1981
BOUNDARY PROCESS CHANGE
K812738 · The Buckeye Cellulose Corp. · Nov 1981
STERILE ADHERENT DRAPES
K812809 · Abco Dealers, Inc. · Nov 1981
3M GERMICIDAL SURGICAL INCISE DRAPE
K801550 · 3M Company · Sep 1981
BACTERICIDAL INCISE DRAPE
K811871 · Surgikos, Inc. · Aug 1981
GATOR DRAPES
K811996 · The Anspach Effort, Inc. · Aug 1981