Cleared Traditional

K915231 - EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS

K915231 is an FDA 510(k) clearance for EPIDURAL INDICATION FOR VOLUMETRIC INFU..., manufactured by Q-Life Systems, Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 61-day FDA review.

K915231 · Q-Life Systems, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
61d
Days
Class 2
Risk

K915231 is an FDA 510(k) clearance for the EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Q-Life Systems, Inc. (Kingston, Ontario, CA). The FDA issued a Cleared decision on January 22, 1992 after a review of 61 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5725 - the FDA general hospital 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 Q-Life Systems, Inc. devices

FDA 510(k) Submission Details - K915231

510(k) Number K915231 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1991
Decision Date January 22, 1992
Days to Decision 61 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 129d · This submission: 61d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FRN Device Classification - Class 2, Special Controls

Product Code FRN Pump, Infusion
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
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 General Hospital devices follow this clearance model.

Regulatory Peers - FRN Pump, Infusion

All 615
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K915231.
PANCRETEC PROVIDER(R) MODEL 5500 INFUS PUMP, MODIF
K913931 · Abbott Laboratories · Mar 1992
FLO-GARD(R) 6201
K915522 · Baxter Healthcare Corp · Feb 1992
FLO-GARD(R) 6301
K915523 · Baxter Healthcare Corp · Feb 1992
PROVIDER APM INFUSION PUMP
K914349 · Abbott Laboratories · Dec 1991
VIVUS PS (PROGRAMMING SOFTWARE)
K913907 · I-Flow Corp. · Dec 1991
PUMPMAN(TM) AMBULATORY DRUG DELIVERY SYSTEM
K911782 · Strato Medical Corp. · Nov 1991