Cleared Traditional

K903571 - MICREL LTD PORTABLE INFUSION MICROPUMP

K903571 is an FDA 510(k) clearance for MICREL LTD PORTABLE INFUSION MICROPUMP, manufactured by Technology Transfer Intl., Inc.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 177-day FDA review.

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

FDA 510(k) Submission Details - K903571

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.

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 615
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K903571.
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STRATOFUSE PCA INFUSER
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AVI MODEL 600 SYRINGE PUMP, MODIFICATION
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BARD AMBULATORY PCA DRUG DELIVERY SYSTEM
K904403 · C.R. Bard, Inc. · Dec 1990
SYRINGE INFUSION PUMP
K903343 · Baxter Healthcare Corp · Nov 1990