Cleared Traditional

K843724 - I.V. START KIT & OBSTETRICAL KIT

K843724 is an FDA 510(k) clearance for I.V. START KIT & OBSTETRICAL KIT, manufactured by E.M. Adams. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 108-day FDA review.

K843724 · E.M. Adams · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1985
Decision
108d
Days
Class 2
Risk

K843724 is an FDA 510(k) clearance for the I.V. START KIT & OBSTETRICAL KIT. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by E.M. Adams (Medfield, US). The FDA issued a Cleared decision on January 10, 1985 after a review of 108 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 E.M. Adams devices

FDA 510(k) Submission Details - K843724

510(k) Number K843724 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 24, 1984
Decision Date January 10, 1985
Days to Decision 108 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 129d · This submission: 108d
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 193
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K843724.
STANGUARD O.R. TOWEL PACK-4TOWEL PACK #278220400
K860447 · Standard Textile Co., Inc. · Feb 1986
ABCO DRAPES/TOWELS
K851314 · Abco Dealers, Inc. · May 1985
SURGICAL DRAPES
K844802 · Procter & Gamble Mfg. Co. · Jan 1985
DRAPE SURGICAL UTILITY DRAPE STERILE
K843496 · Busse Hospital Disposables, Inc. · Oct 1984
ACU-DERM TRANSPARENT INCISE DRAPE
K841735 · Acme United Corp. · Aug 1984
SPUNGARD & SURG. DRAPES-GOWNS & PACKS
K842115 · Kimberly-Clark Corp. · Jun 1984