Cleared Traditional

K893212 - THERMALAP

K893212 is an FDA 510(k) clearance for THERMALAP, manufactured by O.R. Concepts, 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.

K893212 · O.R. Concepts, Inc. · General Hospital
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Jun 1989
Decision
35d
Days
Class 2
Risk

K893212 is an FDA 510(k) clearance for the THERMALAP. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by O.R. Concepts, Inc. (Roanoke, US). The FDA issued a Cleared decision on June 1, 1989 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 O.R. Concepts, Inc. devices

FDA 510(k) Submission Details - K893212

510(k) Number K893212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 27, 1989
Decision Date June 01, 1989
Days to Decision 35 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
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 265
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K893212.
ABSORBABLE GAUZE DRAPE
K901465 · Ulti-Med Intl., Inc. · Jun 1990
MERCY HIP/KNEE PACK
K896215 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
OR TOWEL PACKS
K894764 · Advance Medical Designs, Inc. · Aug 1989
SURGICAL 'LASER' DRAPE
K884231 · Henley Intl. · Apr 1989
O.R. TOWELS (STERILE)
K890709 · Cypress Medical Products, Ltd. · Mar 1989
AM TM SYRGICAL DRAPES
K882643 · Henley Intl. · Mar 1989