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Centricity Perinatal and Centricity Intensive Care

by Ge Healthcare Integrated IT Solutions

510(k) K111614

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 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 NumberK111614 Date26 Sep 2011ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0337-2014 FDA Class II initiated 11 Mar 2013

    1) Under rare network conditions, a Centricity Perinatal process may maintain an incorrect count of Patient slots in use which may lead to an inability to access the patient roster. The user is temporarily unable to review or edit form and chart information. This could result in a potential delay of care; however active fetal strips and permanent patient data storage are not affected. 2) When

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  • Withdrawn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
HGM
Device Class
Class II
Regulation
21 CFR Part 884.2740
Advisory Committee
Obstetrics/Gynecology
FDA Decision
SESE Substantially Equivalent

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