Cleared Traditional

K980738 - PSI-TEC SYRINGE INFUSION PUMP AND ACCES...

K980738 is an FDA 510(k) clearance for PSI-TEC SYRINGE INFUSION PUMP AND ACCES..., 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 111-day FDA review.

K980738 · Byron Medical · General Hospital
Download Printable Device Report (PDF)
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

FDA 510(k) Submission Details - K980738

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
Combination Product No
PCCP Authorized No
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.

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 K980738.
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
K982838 · Sims Deltec, Inc. · Nov 1998
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K982836 · Sims Deltec, Inc. · Nov 1998
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X
K981776 · Alexander Mfg. Co. · Aug 1998
ABBOTT GEMSTAR IV INFUSION PUMP
K974778 · Abbott Laboratories · Mar 1998
SMITH & NEPHEW DYONICS INTELIJET REUSABLE CANNULAS
K980092 · Smith & Nephew, Inc. · Mar 1998
CADD-DIPLOMAT PC COMMUNICATIONS SYSTEM AND THE CADD- AMBASSADOR PUMP COMMUNICATIONS SYSTEM
K973917 · Sims Deltec, Inc. · Jan 1998