Cleared Special

K141654 - THE BELMONT RAPID INFUSER

K141654 is an FDA 510(k) clearance for THE BELMONT RAPID INFUSER, manufactured by Belmont Instrument Corporation. The device is a Class 2 General Hospital device with product code FRN cleared through the Special 510(k) pathway after a 28-day FDA review.

K141654 · Belmont Instrument Corporation · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2014
Decision
28d
Days
Class 2
Risk

K141654 is an FDA 510(k) clearance for the THE BELMONT RAPID INFUSER. Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Belmont Instrument Corporation (Billerica, US). The FDA issued a Cleared decision on July 18, 2014 after a review of 28 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K141654

510(k) Number K141654 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 20, 2014
Decision Date July 18, 2014
Days to Decision 28 days
Submission Type Special
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
101d faster than avg
Panel avg: 129d · This submission: 28d
Pathway characteristics
Modification to existing cleared device.

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 707
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K141654.
SAPPHIRE INFUSION PUMP
K141389 · Q Core Medical , Ltd. · Dec 2014
HALO AMBULATORY INFUSION SYSTEM
K140783 · Zyno Medical, LLC · Oct 2014
ALARIS SYSTEM WITH GUARDRAILS SUITE MX
K133532 · Carefusion 303, Inc. · Aug 2014
HOSPIRA MEDNET MEDICATION MANAGEMENT SUITE
K141102 · Hospira, Inc. · Jul 2014
BAXTER SIGMA SPECTRUM INFUSION PUMP WITH MASTER DRUG LIBRARY
K133801 · Baxter Healthcare Corporation · May 2014
SAPPHIRE INFUSION PUMP
K123049 · Q Core Medical , Ltd. · Oct 2013
K141654 · THE BELMONT RAPID INFUSER
Download PDF FDA Summary Belmont Instrument Co…