Cleared Traditional

MICREL LTD PORTABLE INFUSION MICROPUMP (K903571) - FDA 510(k) Clearance

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

K903571 · Technology Transfer Intl., Inc. · General Hospital
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Feb 1991
Decision
177d
Days
Class 2
Risk

K903571 is an FDA 510(k) clearance for the MICREL LTD PORTABLE INFUSION MICROPUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Technology Transfer Intl., Inc. (Vienna, US). The FDA issued a Cleared decision on February 1, 1991 after a review of 177 days - an extended review 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: 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 Technology Transfer Intl., Inc. devices

Submission Details

510(k) Number K903571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 08, 1990
Decision Date February 01, 1991
Days to Decision 177 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
48d slower than avg
Panel avg: 129d · This submission: 177d
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 232
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K903571.
EPIDURAL INDICATION FOR VOLUMETRIC INFUSION PUMPS
K910428 · Baxter Healthcare Corp · Apr 1991
LARGE VOLUME ELASTOMERIC INFUSION DEVICE ATTACH.
K910425 · Baxter Healthcare Corp · Apr 1991
MODIFIED VOLUMETRIC INFUSION PUMPS ATTACHMENTS
K910523 · Baxter Healthcare Corp · Mar 1991
BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K904403 · C.R. Bard, Inc. · Dec 1990
SYRINGE INFUSION PUMP
K903343 · Baxter Healthcare Corp · Nov 1990
BARD MICROBORE ANTI-SIPHON NITRO SET
K900217 · C.R. Bard, Inc. · Oct 1990