Cleared Traditional

K852200 - SIMPLASTIC SUPRA PUBIC CATHETER

K852200 is an FDA 510(k) clearance for SIMPLASTIC SUPRA PUBIC CATHETER, manufactured by Franklin Medical USA, Inc.. The device is a Class 2 Gastroenterology & Urology device with product code KOB cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K852200 · Franklin Medical USA, Inc. · Gastroenterology & Urology device
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Aug 1985
Decision
78d
Days
Class 2
Risk

K852200 is an FDA 510(k) clearance for the SIMPLASTIC SUPRA PUBIC CATHETER. Classified as Catheter, Suprapubic (and Accessories) (product code KOB), Class II - Special Controls.

Submitted by Franklin Medical USA, Inc. (Atlanta, US). The FDA issued a Cleared decision on August 7, 1985 after a review of 78 days - a notably fast clearance cycle.

This device falls under the Gastroenterology & Urology FDA review panel, regulated under 21 CFR 876.5090 - 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 Franklin Medical USA, Inc. devices

FDA 510(k) Submission Details - K852200

510(k) Number K852200 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 1985
Decision Date August 07, 1985
Days to Decision 78 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 131d · This submission: 78d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KOB Device Classification - Class 2, Special Controls

Product Code KOB Catheter, Suprapubic (and Accessories)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 876.5090
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 - KOB Catheter, Suprapubic (and Accessories)

All 23
Devices cleared under the same product code (KOB) and FDA review panel - the closest regulatory comparables to K852200.
(STAMEY) T.U.R.P. SUPRAPUBIC CATHETER SET
K863120 · Cook Urological, Inc. · Oct 1986
VESICO SUPRAPUBIC BLADDER DRAINAGE & EXCHANGE SETS
K863386 · Angiomed U.S., Inc. · Oct 1986
PERCUTANEOUS PIGTAIL SUPRAPUBLIC CATHETER SET
K852287 · Cook Ob/Gyn · Aug 1985
SEXTON CYSTOTOMY URINE PUMP
K843158 · Holter-Hausner Intl. · Oct 1984
CYSTOFIX SUPRAPUBIC BLADDER DRAIN SET
K813084 · Burron Medical Products, Inc. · Dec 1981
VANCE PERCUTANEOUS MALECOT NEPHROSTOMY
K810368 · Vance Products, Inc. · Mar 1981