Cleared Traditional

FLOWMATE HAND PUMP (K915459) - FDA 510(k) Clearance

Class II Gastroenterology & Urology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K915459 · Psi Medical Products, Inc. · Gastroenterology & Urology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1994
Decision
804d
Days
Class 2
Risk

K915459 is an FDA 510(k) clearance for the FLOWMATE HAND PUMP. Classified as Catheter, Urological (product code KOD), Class II - Special Controls.

Submitted by Psi Medical Products, Inc. (Norwalk, US). The FDA issued a Cleared decision on February 15, 1994 after a review of 804 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Gastroenterology & Urology submissions.

View all Psi Medical Products, Inc. devices

Submission Details

510(k) Number K915459 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 04, 1991
Decision Date February 15, 1994
Days to Decision 804 days
Submission Type Traditional
Review Panel Gastroenterology & Urology (GU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
674d slower than avg
Panel avg: 130d · This submission: 804d
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 38
Devices cleared under the same product code (KOD) and FDA review panel - the closest regulatory comparables to K915459.
IMAGER II UROLOGY TORQUE CATHETER, MODEL 40030X1, 40040X1, AND 40050X1
K011965 · Boston Scientific Corp · Jul 2001
IMAGER TORQUE CATHETER
K965229 · Boston Scientific Corp · Mar 1997
BARD URODYNAMIC CATHETERIZATION PROCEDURE TRAY
K922527 · C.R. Bard, Inc. · Apr 1994
BARD LATEX URINARY CATHETERS
K922431 · C.R. Bard, Inc. · Mar 1993
PHARMASEAL DISPOSABLE ABDOMINAL TROCAR
K904734 · Baxter Healthcare Corp · Nov 1990
BARD CONFORMACATH FOLEY CATHETER
K900229 · C.R. Bard, Inc. · Apr 1990