Skip to content

Rmi Aortic Root/Coronary Sinus Monit./Infusion Set

by Research Medical, Inc.

510(k) K892377

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK892377 Date7 Dec 1989ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-0542-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010
    • Terminated Z-0543-2011 FDA Unclassified (pre-2012) initiated 19 Oct 2010

    Monitoring and Infusion Set connectors may break during manipulation.

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  • Withdrawn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
DTL
Device Class
Class II
Regulation
21 CFR Part 870.4290
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Other devices from Research Medical, Inc.

See all devices from Research Medical, Inc. →