Cleared Traditional

K070529 - AFF (MARK I) VOLUMETRIC INFUSION PUMP

K070529 is an FDA 510(k) clearance for AFF (MARK I) VOLUMETRIC INFUSION PUMP, manufactured by Definitive Medical Technologies, Ltd.. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 74-day FDA review.

K070529 · Definitive Medical Technologies, Ltd. · General Hospital
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May 2007
Decision
74d
Days
Class 2
Risk

K070529 is an FDA 510(k) clearance for the AFF (MARK I) VOLUMETRIC INFUSION PUMP. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Definitive Medical Technologies, Ltd. (Lod, IL). The FDA issued a Cleared decision on May 8, 2007 after a review of 74 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 Definitive Medical Technologies, Ltd. devices

FDA 510(k) Submission Details - K070529

510(k) Number K070529 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2007
Decision Date May 08, 2007
Days to Decision 74 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 129d · This submission: 74d
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 Peers - FRN Pump, Infusion

All 547
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K070529.
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K061108 · Stryker · Feb 2007