Cleared Traditional

K874867 - CATR(TM)-H CARDIOTOMY HOLDER

K874867 is an FDA 510(k) clearance for CATR(TM)-H CARDIOTOMY HOLDER, manufactured by Bentley Laboratories, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KPI cleared through the Traditional 510(k) pathway after a 67-day FDA review.

K874867 · Bentley Laboratories, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1988
Decision
67d
Days
Class 2
Risk

K874867 is an FDA 510(k) clearance for the CATR(TM)-H CARDIOTOMY HOLDER. Classified as Stimulator, Electrical, Non-implantable, For Incontinence (product code KPI), Class II - Special Controls.

Submitted by Bentley Laboratories, Inc. (Irvine, US). The FDA issued a Cleared decision on February 2, 1988 after a review of 67 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5320 - 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.

FDA 510(k) Submission Details - K874867

510(k) Number K874867 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 27, 1987
Decision Date February 02, 1988
Days to Decision 67 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
64d faster than avg
Panel avg: 131d · This submission: 67d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPI Device Classification - Class 2, Special Controls

Product Code KPI Stimulator, Electrical, Non-implantable, For Incontinence
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5320
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 - KPI Stimulator, Electrical, Non-implantable, For Incontinence

All 96
Devices cleared under the same product code (KPI) and FDA review panel - the closest regulatory comparables to K874867.
TBD
K910081 · Empi · Jul 1991
NONIMPLANTED ELECTRICAL CONTINENCE DEVICE
K891007 · Tridak Division of Indicon, Inc. · Jun 1990
MICROGYN II ELEC STIM DEVICE TREAT OF URIN INCONTI
K891773 · Hollister, Inc. · Aug 1989
}IUSTIM - ELECTRONIC NEUROMUSCULAR STIMULATOR
K850167 · Urologics, Inc. · Apr 1985
RADIOISOTOPE CALIBRATOR (CRCO-22NB)
K761145 · G.D. Searle and Co. · Dec 1976
K874867 · CATR(TM)-H CARDIOTOMY HOLDER
Download PDF Bentley Laboratories,…