Cleared Traditional

K981818 - CONVERTORS TRILAMINATE DRAPES

K981818 is an FDA 510(k) clearance for CONVERTORS TRILAMINATE DRAPES, manufactured by Allegiance Healthcare Corp.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 49-day FDA review.

K981818 · Allegiance Healthcare Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1998
Decision
49d
Days
Class 2
Risk

K981818 is an FDA 510(k) clearance for the CONVERTORS TRILAMINATE DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Allegiance Healthcare Corp. (Mcgraw Park, US). The FDA issued a Cleared decision on July 10, 1998 after a review of 49 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 Allegiance Healthcare Corp. devices

FDA 510(k) Submission Details - K981818

510(k) Number K981818 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1998
Decision Date July 10, 1998
Days to Decision 49 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
80d faster than avg
Panel avg: 129d · This submission: 49d
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 296
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K981818.
SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600
K990253 · Amba Medical , Ltd. · Sep 1999
HAL SCOPE HOLDER SYSTEM
K991548 · Noved Medical · Jun 1999
OPERATING ROOM TOWELS
K981823 · Baldur Systems Corp. · Aug 1998
VARIOUS SURGICAL OR PATIENT DRAPES
K980210 · Gel-Lite, LLC · May 1998
MSI SURGICAL DRAPES
K974672 · Medical Specialty Innovations, Inc. (Msi) · Mar 1998
PROMAX SURGICAL DRAPES AND COVERS
K980183 · Standard Textile Co., Inc. · Feb 1998