Cleared Traditional

K980210 - VARIOUS SURGICAL OR PATIENT DRAPES

K980210 is an FDA 510(k) clearance for VARIOUS SURGICAL OR PATIENT DRAPES, manufactured by Gel-Lite, LLC. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 114-day FDA review.

K980210 · Gel-Lite, LLC · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
114d
Days
Class 2
Risk

K980210 is an FDA 510(k) clearance for the VARIOUS SURGICAL OR PATIENT DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Gel-Lite, LLC (Jacksonville, US). The FDA issued a Cleared decision on May 15, 1998 after a review of 114 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Gel-Lite, LLC devices

FDA 510(k) Submission Details - K980210

510(k) Number K980210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 21, 1998
Decision Date May 15, 1998
Days to Decision 114 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
15d faster than avg
Panel avg: 129d · This submission: 114d
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 229
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K980210.
SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600
K990253 · Amba Medical , Ltd. · Sep 1999
OPERATING ROOM TOWELS
K981823 · Baldur Systems Corp. · Aug 1998
CONVERTORS TRILAMINATE DRAPES
K981818 · Allegiance Healthcare Corp. · Jul 1998
MSI SURGICAL DRAPES
K974672 · Medical Specialty Innovations, Inc. (Msi) · Mar 1998
PROMAX SURGICAL DRAPES AND COVERS
K980183 · Standard Textile Co., Inc. · Feb 1998
FANFOLD DRAPE 41 X 57 PRODUCT NO. 900-633, RECORDER NO. 0633
K974647 · Customed, Inc. · Jan 1998