Cleared Traditional

K980183 - PROMAX SURGICAL DRAPES AND COVERS

K980183 is an FDA 510(k) clearance for PROMAX SURGICAL DRAPES AND COVERS, manufactured by Standard Textile Co., Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K980183 · Standard Textile Co., Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
37d
Days
Class 2
Risk

K980183 is an FDA 510(k) clearance for the PROMAX SURGICAL DRAPES AND COVERS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Standard Textile Co., Inc. (Cincinnati, US). The FDA issued a Cleared decision on February 26, 1998 after a review of 37 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 Standard Textile Co., Inc. devices

FDA 510(k) Submission Details - K980183

510(k) Number K980183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 1998
Decision Date February 26, 1998
Days to Decision 37 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
92d faster than avg
Panel avg: 129d · This submission: 37d
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 202
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K980183.
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
K994211 · Dentsply Intl. · Feb 2000
CONVERTORS SURGICAL DRAPES
K993795 · Allegiance Healthcare Corp. · Jan 2000
CONVERTORS TRILAMINATE DRAPES
K981818 · Allegiance Healthcare Corp. · Jul 1998
FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
K974647 · Customed, Inc. · Jan 1998
CONVERTORS SMS DRAPES
K970554 · Allegiance Healthcare Corp. · May 1997
EYE TRAY
K970722 · Trinity Laboratories, Inc. · Mar 1997