Cleared Traditional

K991667 - BROADLINE OR TOWELS

K991667 is an FDA 510(k) clearance for BROADLINE OR TOWELS, manufactured by Broadline Medical Industries. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 136-day FDA review.

K991667 · Broadline Medical Industries · General Hospital
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Sep 1999
Decision
136d
Days
Class 2
Risk

K991667 is an FDA 510(k) clearance for the BROADLINE OR TOWELS. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Broadline Medical Industries (Inverness, US). The FDA issued a Cleared decision on September 27, 1999 after a review of 136 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 Broadline Medical Industries devices

FDA 510(k) Submission Details - K991667

510(k) Number K991667 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 14, 1999
Decision Date September 27, 1999
Days to Decision 136 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 129d · This submission: 136d
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 230
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K991667.
CONVERTORS EQUIPMENT DRAPES
K000417 · Allegiance Healthcare Corp. · Mar 2000
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
OPERATING ROOM TOWELS
K981823 · Baldur Systems Corp. · Aug 1998
CONVERTORS TRILAMINATE DRAPES
K981818 · Allegiance Healthcare Corp. · Jul 1998