510(k) · Cleared
Recalled · Class I · 2023Ohmeda-Ohio Care Plus Incubator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohmeda Medical · FMZ Incubator, Neonatal
Cleared on Feb 12, 1998 after an 85-day review. The FDA summary names its predicate without a number. 1 of the 3 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 2 times, including a Class I recall.
- Decided
- Feb 12, 1998
- Review
- 85 days
- Class
- Class II
- Product code
- FMZ
- Recalls
- 2 (1 Class I)
- Predicates
- 0
2 later devices descend from it, 2 citing it directly. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- This deviceK974349 Ohmeda-Ohio Care Plus IncubatorOhmeda Medical · 1998
- Descendant · cites it directly · 0 of its ownK071977 Tarry Medical Temperature ProbesTarry Medical Products, Inc. · 2008
- Descendant · cites it directly · 0 of its ownK040910 Infant Incubator, Model CHS-I1000Choong Wae Medical Corp. · 2004
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K974349 | Ohmeda-Ohio Care Plus Incubator | Ohmeda Medical | 1998 | — |
| +1 | K071977 | Tarry Medical Temperature Probes | Tarry Medical Products, Inc. | 2008 | — |
| +1 | K040910 | Infant Incubator, Model CHS-I1000 | Choong Wae Medical Corp. | 2004 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
1 device in this family has a Class I recall. A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new FMZ device
- #1 K251663 Giraffe OmniBed Carestation (CS1); Giraffe…score 14.4 · 5 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | — | Care Plus Incubator Named without a submission number |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 26, 2023 | Class I | Z-0957-2024 | Labeling design | 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 upright and look closed but not be latched… |
| Nov 18, 2016 | Class II | Z-1510-2017 | Under Investigation by firm | 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 fire, charring, smoke, or sparking where… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K071977 (Tarry Medical Products, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FMZ devicesFMZ Incubator, Neonatal: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMZ
60in 2010
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMZ
2in 2024
Class I (11 since 2007) Class II/III not classified
Adverse event reports per year · FMZ
250in 2025
MAUDE reports naming product code FMZ, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 3 | 81 | 0 | 14 |
| 2008 | 1 | — | 4 | 10 |
| 2009 | 0 | — | 0 | 8 |
| 2010 | 4 | 60 | 0 | 11 |
| 2011 | 1 | — | 5 | 10 |
| 2012 | 0 | — | 0 | 12 |
| 2013 | 0 | — | 1 (1) | 11 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 9 |
| 2016 | 1 | — | 1 | 12 |
| 2017 | 1 | — | 0 | 4 |
| 2018 | 2 | — | 3 | 18 |
| 2019 | 2 | — | 1 | 24 |
| 2020 | 0 | — | 0 | 8 |
| 2021 | 0 | — | 0 | 15 |
| 2022 | 1 | — | 0 | 27 |
| 2023 | 0 | — | 8 (8) | 19 |
| 2024 | 0 | — | 2 (2) | 118 |
| 2025 | 2 | — | 0 | 250 |
| 2026 | 2 | — | 3 | — |
What is it indicated for?
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…
Read the full statement (213 words)
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K974349 · printed Nov 4, 2026
Cite this page
510(k) Report. “K974349: Ohmeda-Ohio Care Plus Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K974349
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026