Cleared Traditional

K090736 - POWER INFUSER, MODEL M100B-3A

K090736 is an FDA 510(k) clearance for POWER INFUSER, manufactured by ZOLL Medical Corporation. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 62-day FDA review.

K090736 · ZOLL Medical Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2009
Decision
62d
Days
Class 2
Risk

K090736 is an FDA 510(k) clearance for the POWER INFUSER, MODEL M100B-3A. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by ZOLL Medical Corporation (Chelmsford, US). The FDA issued a Cleared decision on May 20, 2009 after a review of 62 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 - K090736

510(k) Number K090736 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 19, 2009
Decision Date May 20, 2009
Days to Decision 62 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 129d · This submission: 62d
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 846
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K090736.
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K090087 · Iradimed Corporation · Apr 2009
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K081412 · Hospira, Inc. · Dec 2008
K090736 · POWER INFUSER, MODEL M100B-3A
Download PDF FDA Summary ZOLL Medical Corporat…