Cleared Traditional

K172653 - Power Infuser

K172653 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 316-day FDA review.

K172653 · ZOLL Medical Corporation · General Hospital
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Jul 2018
Decision
316d
Days
Class 2
Risk

K172653 is an FDA 510(k) clearance for the Power Infuser. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by ZOLL Medical Corporation (Chelsmford, US). The FDA issued a Cleared decision on July 18, 2018 after a review of 316 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 ZOLL Medical Corporation devices

FDA 510(k) Submission Details - K172653

510(k) Number K172653 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 05, 2017
Decision Date July 18, 2018
Days to Decision 316 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
187d slower than avg
Panel avg: 129d · This submission: 316d
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 581
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K172653.
Sapphire Infusion Pump, Sapphire administration sets
K192860 · Q Core Medical , Ltd. · Nov 2020
Ivenix Infusion System (IIS)
K183311 · Ivenix, Inc. · Jun 2019
Unity Subcutaneous Delivery System for Remodulin
K190182 · DEKA Research & Development · May 2019
Perfusor® Space Syringe Infusion Pump System
K172831 · B.Braun Medical, Inc. · Jun 2018
Spectrum IQ Infusion System, Dose IQ Safety Software
K173084 · Baxter Healthcare Corporation · May 2018
Integrated Catch-up Freedom Syringe Driver Infusion System
K162613 · Repro-Med Systems, Inc. Dba Rms Medical Products · Aug 2017