Cleared Traditional

K910335 - MTP TRANSPORT INFUSION PUMP

K910335 is the FDA 510(k) clearance for MTP TRANSPORT INFUSION PUMP by Medical Technical Products. It is a Class 2 General Hospital device (product code FRN) cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K910335 · Medical Technical Products · General Hospital
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Mar 1991
Decision
47d
Days
Class 2
Risk

K910335 is an FDA 510(k) clearance for the MTP TRANSPORT INFUSION PUMP, MODEL NO. MTPLEA. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Medical Technical Products (Huntington, US). The FDA issued a Cleared decision on March 13, 1991 after a review of 47 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 Medical Technical Products devices

Submission Details

510(k) Number K910335 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 25, 1991
Decision Date March 13, 1991
Days to Decision 47 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
82d faster than avg
Panel avg: 129d · This submission: 47d
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 444
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K910335.
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