Cleared Traditional

K874293 - ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET

K874293 is an FDA 510(k) clearance for ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET, manufactured by Ackrad Laboratories. The device is a Class 2 Gastroenterology & Urology device with product code KOD cleared through the Traditional 510(k) pathway after a 70-day FDA review.

K874293 · Ackrad Laboratories · Gastroenterology & Urology device
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Dec 1987
Decision
70d
Days
Class 2
Risk

K874293 is an FDA 510(k) clearance for the ACKRAD V/CUG VOIDING CYSTOURETHROGRAPHY SET. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Ackrad Laboratories (Cranford, US). The FDA issued a Cleared decision on December 29, 1987 after a review of 70 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 Ackrad Laboratories devices

FDA 510(k) Submission Details - K874293

510(k) Number K874293 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 20, 1987
Decision Date December 29, 1987
Days to Decision 70 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
60d faster than avg
Panel avg: 130d · This submission: 70d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOD Device Classification - Class 2, Special Controls

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 136
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K874293.
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PHARMASEAL RUBBER URETHRAL CATHETER
K874517 · American Pharmaseal Div. Ahsc · Dec 1987