# K974349: Ohmeda-Ohio Care Plus Incubator

- Pathway: 510(k) (Traditional)
- Applicant: Ohmeda Medical
- Decided: Feb 12, 1998 after 85 days
- Product code: FMZ (Incubator, Neonatal)
- Device class: 2
- Regulation: 21 CFR 880.5400
- Recalls of this device: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
2 later devices descend from it; 2 cite it directly.
1 of 3 devices in its family (counting itself) has 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) Care Plus Incubator: named in the summary without a submission number

## Most influential descendants
- K071977: Tarry Medical Temperature Probes (2008), 0 descendants of its own
- K040910: Infant Incubator, Model CHS-I1000 (2004), 0 descendants of its own

## Recalls of this device
- Dec 26, 2023 · Class I · Z-0957-2024: GE HealthCare has become aware that the bedside panel of Care Plus, Care Plus Model 1000, 2000, 3000 and 4000 Incubator, Lullaby Incubator, Lullaby TR Incubator, and Lullaby XP Incubator can be uprigh
- Nov 18, 2016 · Class II · Z-1510-2017: Certain power cords could overheat. The affected power cords were manufactured by Electric-Cord and are referred to as Taller Bridge power cords. The overheating of the power cord could result in fi

## Indications for use
Incubators provide a controlled thermal environment for neonates who are unable to provide their own thermoregulation. They may also be used for short periods of time to facilitate the neonate’s transition from the uterus to the external environment. Most incubators can be used in two operating modes: 1. Air Control: The clinician sets the appropriate air temperature for maintaining the desired patient temperature. The air temperature is initially selected based on the clinician’s training and experience and then is adjusted based on the patients needs and clinical status. 2. Patient Control: The clinician sets the desired patient temperature. A skin temperature probe senses the patient temperature and feeds this information to the controller of the incubator. The controller then adjusts the heater output to maintain the patient temperature at the set value. These adjustments to the heater output are made in such a way to gradually change the patient’s temperature while minimizing overshooting and patient stress. Incubators have alarms to alert clinicians when certain patient or equipment conditions occur, such as a malfunction, or an excessive departure of the patient’s temperature from the set value. Incubators may incorporate other features, such as humidification of the infant environment, tilting of the bed, oxygen supply, and data output to remote monitors or nurse call systems.

Source page: https://510kreport.com/device/K974349
Methodology: https://510kreport.com/methodology