Cleared Traditional

IMS MINIATURE VOLUMETRIC INFUSION PUMP (K830454) - FDA 510(k) Clearance

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

K830454 · Ziehm International, Inc. · General Hospital
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Mar 1983
Decision
44d
Days
Class 2
Risk

K830454 is an FDA 510(k) clearance for the IMS MINIATURE VOLUMETRIC INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Ziehm International, Inc. (Annapolis, US). The FDA issued a Cleared decision on March 31, 1983 after a review of 44 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Ziehm International, Inc. devices

Submission Details

510(k) Number K830454 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 15, 1983
Decision Date March 31, 1983
Days to Decision 44 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d faster than avg
Panel avg: 129d · This submission: 44d
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 231
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K830454.
PCA PUMP
K830452 · Abbott Laboratories · Apr 1983
INFUSION PUMP #AS*6H
K830486 · Baxter Healthcare Corp · Apr 1983
GRASE BY DYNAMICS MS 27 SYRINGE DRIVER
K830809 · Intermedics, Inc. · Apr 1983
SYRINGE DRIVER MS-16
K830423 · Intermedics, Inc. · Mar 1983
HARVARD APPARATUS INTERMITTENT INFUSION
K830102 · C.R. Bard, Inc. · Feb 1983
EXTERNAL INFUSION PUMP
K830151 · Intermedics, Inc. · Feb 1983