Cleared Traditional

K242735 - Belmont Rapid Infuser

Also marketed or referenced as:
Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)

K242735 is an FDA 510(k) clearance for Belmont Rapid Infuser, manufactured by Belmont Medical Technologies. The device is a Class 2 General Hospital device with product code FRN cleared through the Traditional 510(k) pathway after a 103-day FDA review.

K242735 · Belmont Medical Technologies · General Hospital
Download Printable Device Report (PDF)
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Dec 2024
Decision
103d
Days
Class 2
Risk

K242735 is an FDA 510(k) clearance for the Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min). Classified as Pump, Infusion (product code FRN), Class II - Special Controls.

Submitted by Belmont Medical Technologies (Billerica, US). The FDA issued a Cleared decision on December 23, 2024 after a review of 103 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 Belmont Medical Technologies devices

FDA 510(k) Submission Details - K242735

510(k) Number K242735 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2024
Decision Date December 23, 2024
Days to Decision 103 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
26d faster than avg
Panel avg: 129d · This submission: 103d
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 459
Devices cleared under the same product code (FRN) and FDA review panel - the closest regulatory comparables to K242735.
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Curlin 8000 Ambulatory Infusion System
K242660 · Zevex, Inc. · Oct 2024
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K242390 · Baxter Healthcare Corporation · Sep 2024
Curlin 8000 Ambulatory Infusion System
K232793 · Zevex, Inc. · May 2024