Cleared Traditional

K830723 - REDI-DRAPE

K830723 is an FDA 510(k) clearance for REDI-DRAPE, manufactured by The Oec Group. 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.

K830723 · The Oec Group · General Hospital
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Apr 1983
Decision
35d
Days
Class 2
Risk

K830723 is an FDA 510(k) clearance for the REDI-DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by The Oec Group (Mchenry, US). The FDA issued a Cleared decision on April 12, 1983 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 The Oec Group devices

FDA 510(k) Submission Details - K830723

510(k) Number K830723 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 1983
Decision Date April 12, 1983
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 276
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K830723.
LIGHT HANDLE COVER
K832278 · Concept, Inc. · Sep 1983
ISOVIS WOUND PROTECTOR
K832874 · Ritmed, Inc. · Sep 1983
ISOVIS WOUND PROTECTOR
K830270 · Ritmed, Inc. · Jun 1983
GORE-TEX BARRIER SURG. DRAPES & GOWNS
K822641 · W.L. Gore & Associates, Inc. · Jan 1983
BARRIER ANTIMICROBIAL INCISE DRAPE
K820543 · Surgikos, Inc. · Jul 1982
SURGIKOS INCISE DRAPE
K820542 · Surgikos, Inc. · Jun 1982