Cleared Traditional

PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION (K980738) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980738 · Byron Medical · General Hospital
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Optimized for regulatory review, auditing and printing
Jun 1998
Decision
111d
Days
Class 2
Risk

K980738 is an FDA 510(k) clearance for the PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INF.... 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 16, 1998 after a review of 111 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

Submission Details

510(k) Number K980738 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 25, 1998
Decision Date June 16, 1998
Days to Decision 111 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
18d faster than avg
Panel avg: 129d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 220
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K980738.
ACCLAIM INFUSION PUMP
K991501 · Abbott Laboratories · May 1999
ABBOTT PLUM A+ INFUSION PUMP
K982159 · Abbott Laboratories · Jan 1999
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · Abbott Laboratories · Nov 1998
ABBOTT GEMSTAR IV INFUSION PUMP
K974778 · Abbott Laboratories · Mar 1998
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
K980092 · Smith & Nephew, Inc. · Mar 1998
COLLEAGUE 2 VOLUMETRIC INFUSION PUMP(DUAL CHANNEL)/COLLEAGUE 3 VOLUMETRIC INFUSION PUMP(TREE CHANNEL)
K961703 · Baxter Healthcare Corp · Jul 1996