Cleared Traditional

K051252 - MICROPUMP MP-101

K051252 is an FDA 510(k) clearance for MICROPUMP MP-101, manufactured by Micrel Medical Devices S.A.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K051252 · Micrel Medical Devices S.A. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2005
Decision
11d
Days
Class 2
Risk

K051252 is an FDA 510(k) clearance for the MICROPUMP MP-101. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Micrel Medical Devices S.A. (Pallini, GR). The FDA issued a Cleared decision on May 27, 2005 after a review of 11 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.

FDA 510(k) Submission Details - K051252

510(k) Number K051252 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 2005
Decision Date May 27, 2005
Days to Decision 11 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
118d faster than avg
Panel avg: 129d · This submission: 11d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 Consultant

Tuv America, Inc.
STEFAN PREISS

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRN Pump, Infusion

All 778
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K051252.
CRONO GO.
K052219 · Cane S.R.L. · Sep 2005
HOSPIRA PLUM A+ INFUSION PUMP SYSTEM V11.5, HOSPIRA PLUM A+ 3 INFUSION PUMP SYSTEM, V11.5
K052052 · Hospira, Inc. · Aug 2005
SIMPLECHOICE 3.0 ML RESERVOIR PRO REFERENCE NUMBER RP-30
K051045 · Spectrx, Inc. · Aug 2005
PAINPUMP2
K043466 · Stryker Instruments · May 2005
INFPUMP INFILTRATION PUMP
K050324 · Carolina Medical, Inc. · Apr 2005
VEINNOVATIONS INFILTRATION SYSTEM
K050474 · Veinnovations, LLC · Apr 2005

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

K051252 · MICROPUMP MP-101
Download PDF FDA Summary Micrel Medical Device…