Cleared Traditional

K831567 - FOLEY-TEMP

K831567 is the FDA 510(k) clearance for FOLEY-TEMP by Mallinckrodt Critical Care. It is a Class 2 Gastroenterology & Urology device (product code KOD) cleared through the Traditional 510(k) pathway after a 86-day FDA review.

K831567 · Mallinckrodt Critical Care · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 1983
Decision
86d
Days
Class 2
Risk

K831567 is an FDA 510(k) clearance for the FOLEY-TEMP. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Mallinckrodt Critical Care (Mchenry, US). The FDA issued a Cleared decision on August 10, 1983 after a review of 86 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5130 - the FDA gastroenterology and urology 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 Mallinckrodt Critical Care devices

Submission Details

510(k) Number K831567 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1983
Decision Date August 10, 1983
Days to Decision 86 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 130d · This submission: 86d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KOD Catheter, Urological
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5130
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 Gastroenterology & Urology devices follow this clearance model.

Regulatory Peers - KOD Catheter, Urological

All 127
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K831567.
CATHETER CARE TRAY
K832389 · Inmed Corp. · Sep 1983
STERILE FOLEY CATHETERS & UROLOGICAL
K831743 · Electromedics, Inc. · Sep 1983
CURITY CATHETER STRAP
K832692 · The Kendal Co. · Sep 1983
IMPROVED SILICATH SILICONE ELASTOMER
K832165 · Travenol Laboratories, S.A. · Aug 1983
URETERAL STONE EXTRACTOR CATHETER
K831244 · American Edwards Laboratories · Jun 1983
STERILE, ALL PURPOSE URETHRAL CATHETER
K830444 · Abco Dealers, Inc. · Mar 1983