Cleared Special

K983321 - MICROFUSE DUAL RATE INFUSER

K983321 is an FDA 510(k) clearance for MICROFUSE DUAL RATE INFUSER, manufactured by Baxa Corp.. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 14-day FDA review.

K983321 · Baxa Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1998
Decision
14d
Days
Class 2
Risk

K983321 is an FDA 510(k) clearance for the MICROFUSE DUAL RATE INFUSER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Baxa Corp. (Sandy, US). The FDA issued a Cleared decision on October 6, 1998 after a review of 14 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Baxa Corp. devices

FDA 510(k) Submission Details - K983321

510(k) Number K983321 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 22, 1998
Decision Date October 06, 1998
Days to Decision 14 days
Submission Type Special
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
115d faster than avg
Panel avg: 129d · This submission: 14d
Pathway characteristics
Modification to existing cleared device.

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 533
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K983321.
ABBOTT LIFECARE STANDARD TUBING INFUSION PUMP
K983838 · Abbott Laboratories · Nov 1998
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K982838 · Sims Deltec, Inc. · Nov 1998
CADD-LEGACY PLUS AMBULATORY INFUSION SYSTEM
K982836 · Sims Deltec, Inc. · Nov 1998
METRON QA-IDS I.V. PUMP TESTER
K982020 · Metron U.S., Inc. · Sep 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