Cleared Traditional

K040149 - PSI-TEC PERISTALTIC INFILTRATION PUMP

K040149 is an FDA 510(k) clearance for PSI-TEC PERISTALTIC INFILTRATION PUMP, manufactured by Byron Medical. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K040149 · Byron Medical · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2004
Decision
132d
Days
Class 2
Risk

K040149 is an FDA 510(k) clearance for the PSI-TEC PERISTALTIC INFILTRATION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Byron Medical (Tucson, US). The FDA issued a Cleared decision on June 3, 2004 after a review of 132 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Byron Medical devices

FDA 510(k) Submission Details - K040149

510(k) Number K040149 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 2004
Decision Date June 03, 2004
Days to Decision 132 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
3d slower than avg
Panel avg: 129d · This submission: 132d
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 454
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K040149.
BAXTER INFUSOR SV (SMALL VOLUME)
K041738 · Baxter Healthcare Corporation · Jul 2004
HOSPIRA PHOENIX INFUSION SYSTEM WITH HOSPIRA MEDNET SOFTWARE
K041550 · Abbott Laboratories · Jun 2004
COLLEAGUE VOLUMETRIC INFUSION PUMPS
K041191 · Baxter Healthcare Corp · Jun 2004
MEDEX 3000 SERIES MR SYRINGE INFUSION PUMP
K040899 · Medex, Inc. · Apr 2004
MEDTRONIC MINIMED MMT-407C AMBULATORY INFUSION PUMP, MODEL MMT-407C
K040061 · Medtronic Minimed · Apr 2004
ABBOTT DATA PORT PC, MODEL 12181
K040114 · Abbott Laboratories · Jan 2004