Cleared Traditional

K872585 - CHURCHILL-CATH

K872585 is the FDA 510(k) clearance for CHURCHILL-CATH by Churchill Corp.. It is a Class 2 General Hospital device (product code FOZ) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K872585 · Churchill Corp. · General Hospital
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Oct 1987
Decision
106d
Days
Class 2
Risk

K872585 is an FDA 510(k) clearance for the CHURCHILL-CATH. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), Class II - Special Controls.

Submitted by Churchill Corp. (Langhorne, US). The FDA issued a Cleared decision on October 15, 1987 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5200 - 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 Churchill Corp. devices

Submission Details

510(k) Number K872585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 1987
Decision Date October 15, 1987
Days to Decision 106 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
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 242
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K872585.
HR(TM) INTRAVASCULAR CATHETER
K881666 · Icu Medical, Inc. · May 1988
J&J SCALP VEIN INFUSION SETS
K875177 · Critikon Company, LLC · Jan 1988
VASCULAR ACCESS CATHETER W/ANTIMICROBIAL CUFF
K873050 · C.R. Bard, Inc. · Oct 1987
CAVAFIX(R) CENTRAL VENOUS CATHETER KIT W/SUTURE
K870403 · Burron Medical Products, Inc. · May 1987
INSTRUCTION CHANGE FOR RIGHT ATRIAL/RAAF CATHETER
K864949 · Quinton, Inc. · Feb 1987
ARROW 18GA TWO-LUMEN INTRAVENOUS CATH/23GA NEEDLE
K862153 · Arrow Intl., Inc. · Dec 1986