Cleared Traditional

K981823 - OPERATING ROOM TOWELS

K981823 is an FDA 510(k) clearance for OPERATING ROOM TOWELS, manufactured by Baldur Systems Corp.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K981823 · Baldur Systems Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1998
Decision
81d
Days
Class 2
Risk

K981823 is an FDA 510(k) clearance for the OPERATING ROOM TOWELS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Baldur Systems Corp. (Asheville, US). The FDA issued a Cleared decision on August 11, 1998 after a review of 81 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 Baldur Systems Corp. devices

FDA 510(k) Submission Details - K981823

510(k) Number K981823 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1998
Decision Date August 11, 1998
Days to Decision 81 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
48d faster than avg
Panel avg: 129d · This submission: 81d
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 K981823.
ACUCAM INTRAORAL CAMERA SHEATHS, MODELS 023545, 601111, 300407, 601285
K994211 · Dentsply Intl. · Feb 2000
CONVERTORS SURGICAL DRAPES
K993795 · Allegiance Healthcare Corp. · Jan 2000
SECURLINE OPERATING ROOM CAMERA DRAPE, MODEL 3600
K990253 · Amba Medical , Ltd. · Sep 1999
CONVERTORS TRILAMINATE DRAPES
K981818 · Allegiance Healthcare Corp. · Jul 1998
VARIOUS SURGICAL OR PATIENT DRAPES
K980210 · Gel-Lite, LLC · May 1998
MSI SURGICAL DRAPES
K974672 · Medical Specialty Innovations, Inc. (Msi) · Mar 1998