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Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 1000 ml/min); Belmont Rapid Infuser, RI-2 (Rapid Infuser RI-2, 750 ml/min)

by Belmont Medical Technologies

510(k) K242735

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

2 ongoing

This device is named in the recall

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK242735 Date23 Dec 2024ClearedStatusActive

Recalls

2 recalls · 2 ongoing · FDA

    • Ongoing Z-1678-2025 FDA Class II initiated 31 Mar 2025 on shared 510(k) K242735

    Potential crack in the female connector located on the Heat Exchanger/patient line set, which will lead to a fluid leak through the crack during priming of the Rapid Infuser.

    • Ongoing Z-1099-2025 FDA Class II initiated 2 Jan 2025

    Disposable set may leak during priming from a female quick connector due to a crack in the female quick connector, may lead to a potential delay in treatment since the set will need to be replaced by another set

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FRN
Models / Variants
Device Class
Class II
Regulation
21 CFR Part 880.5725
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

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