Cleared Traditional

K982020 - METRON QA-IDS I.V. PUMP TESTER

K982020 is an FDA 510(k) clearance for METRON QA-IDS I.V. PUMP TESTER, manufactured by Metron U.S., Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K982020 · Metron U.S., Inc. · General Hospital
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Sep 1998
Decision
113d
Days
Class 2
Risk

K982020 is an FDA 510(k) clearance for the METRON QA-IDS I.V. PUMP TESTER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Metron U.S., Inc. (Crofton, US). The FDA issued a Cleared decision on September 30, 1998 after a review of 113 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 Metron U.S., Inc. devices

FDA 510(k) Submission Details - K982020

510(k) Number K982020 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 09, 1998
Decision Date September 30, 1998
Days to Decision 113 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
16d faster than avg
Panel avg: 129d · This submission: 113d
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 531
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K982020.
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · Abbott Laboratories · Nov 1998
CADD-LEGACY 1 AMBULATORY INFUSION SYSTEM MODEL NUMBER 6400
K982838 · Sims Deltec, Inc. · Nov 1998
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
K982836 · Sims Deltec, Inc. · Nov 1998
BRIDGE SENTRY BEDSIDE UNIT, BRIDGE SENTRY ADMINISTRATION SET-STANDARD CONFIGURATION, BRIDGE SENTRY ADMINISTRATION SET 5
K973593 · Bridge Medical, Inc. · Aug 1998
ALEXANDER MANUFACTURING CO. BATTERY PART NUMBER MC146X
K981776 · Alexander Mfg. Co. · Aug 1998
PSI-TEC SYRINGE INFUSION PUMP AND ACCESSORIES FOR GENERAL FLUID IRRIGAION/INFILTRATION
K980738 · Byron Medical · Jun 1998