# K111614: Centricity Perinatal and Centricity Intensive Care

- Pathway: 510(k) (Traditional)
- Applicant: Ge Healthcare Integrated IT Solutions
- Decided: Sep 26, 2011 after 110 days
- Product code: HGM (System, Monitoring, Perinatal)
- Device class: 2
- Regulation: 21 CFR 884.2740
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Centricity® Perinatal and Centricity Intensive Care (formerly known as Quantitative Sentinel (QS) System): named in the summary without a submission number

## Recalls of this device
- Mar 11, 2013 · Class II · Z-0337-2014: 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 tempor

## Indications for use
The Centricity Perinatal and Centricity Intensive Care (CPN-CIC) is a clinical information system used to manage clinical data. The CPN-CIC may be used in the following clinical settings such as: * Labor and Delivery (Antepartum, Intrapartum) * Postpartum * Newborn Nursery * Critical Care Units (Neonatal Intensive Care, Adult Intensive Care) The CPN-CIC can be used in the hospitals, physician offices, and outpatient clinics where the system can accept and display data from the following sources such as: * Physiologic devices * External hospital and clinical information systems NOTE: This product does not replace clinical observation and evaluation of the patient at regular intervals by a qualified healthcare provider, who will make diagnoses and decide on treatments and/or interventions. Features of the product are intended to support clinical decision making and should be used in combination with other clinical inputs, such as real time patient observation, physical exam findings and information contained within other systems or recording tools. The product is not intended to be used as a primary monitoring or diagnostic device.

Source page: https://510kreport.com/device/K111614
Methodology: https://510kreport.com/methodology