510(k) · Cleared
Recalled · Class II · 2017Ohio Infant Warmer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ohmeda Medical · FMT Warmer, Infant Radiant
Cleared on Apr 23, 1993 after a 374-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it. It has been recalled once.
- Decided
- Apr 23, 1993
- Review
- 374 days
- Class
- Class II
- Product code
- FMT
- Recalls
- 1
- Predicates
- 0
3 later devices descend from it, 3 citing it directly.
- This deviceK921766 Ohio Infant Warmer SystemOhmeda Medical · 1993
- Descendant · cites it directly · 0 of its ownK972885 Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual…Fisher & Paykel Electronics, Ltd. · 1997
- Descendant · cites it directly · 0 of its ownK971695 Servo-Control Cosycot Infant Warmer, Manual-Control Cosycot Infant…Fisher & Paykel Electronics, Ltd. · 1997
- Descendant · cites it directly · 0 of its ownK971461 Servo-Control Wall-Mount Infant Warmer (IW980)/Manual-Control…Fisher & Paykel Electronics, Ltd. · 1997 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K972885Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual Control Wall-Mount…Fisher & Paykel Electronics, Ltd. · 1997 · cites it directly0descendants
- K971695Servo-Control Cosycot Infant Warmer, Manual-Control Cosycot Infant WarmerFisher & Paykel Electronics, Ltd. · 1997 · cites it directly0descendants
- K971461Servo-Control Wall-Mount Infant Warmer (IW980)/Manual-Control Wall-Mount Infant Warmer…Fisher & Paykel Electronics, Ltd. · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K921766 | Ohio Infant Warmer System | Ohmeda Medical | 1993 | — |
| +1 | K972885 | Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual Control… | Fisher & Paykel Electronics, Ltd. | 1997 | — |
| +1 | K971695 | Servo-Control Cosycot Infant Warmer, Manual-Control Cosycot Infant Warmer | Fisher & Paykel Electronics, Ltd. | 1997 | — |
| +1 | K971461 | Servo-Control Wall-Mount Infant Warmer (IW980)/Manual-Control Wall-Mount… | Fisher & Paykel Electronics, Ltd. | 1997 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMT? 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 FMT device
- #1 K243606 Babyroo TN300score 9.3 · 3 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K972885 | Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual Control Wall-Mount… | 1997 | 0 |
| K971695 | Servo-Control Cosycot Infant Warmer, Manual-Control Cosycot Infant Warmer | 1997 | 0 |
| K971461 | Servo-Control Wall-Mount Infant Warmer (IW980)/Manual-Control Wall-Mount Infant Warmer… | 1997 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 5, 2017 | Class II | Z-2323-2017 | Under Investigation by firm | GE Healthcare has recently become aware of a potential safety issue related to loose screws in the Heater Head of the Infant Warmer System (IWS). Hot screws from the Heater Head of the IWS could fall onto the bed if the Heater Head … |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K972885 (Fisher & Paykel Electronics, Ltd., 1997) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FMT devicesFMT Warmer, Infant Radiant: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMT
103in 2012
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMT
4in 2019
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · FMT
359in 2025
MAUDE reports naming product code FMT, 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 | 2 | — | 0 | 21 |
| 2008 | 0 | — | 1 | 114 |
| 2009 | 1 | — | 2 | 80 |
| 2010 | 1 | — | 0 | 106 |
| 2011 | 1 | — | 0 | 79 |
| 2012 | 4 | 103 | 0 | 54 |
| 2013 | 1 | — | 2 | 55 |
| 2014 | 0 | — | 1 | 79 |
| 2015 | 0 | — | 1 | 56 |
| 2016 | 0 | — | 1 | 56 |
| 2017 | 0 | — | 0 | 46 |
| 2018 | 1 | — | 4 | 79 |
| 2019 | 0 | — | 4 (4) | 1,437 |
| 2020 | 2 | — | 0 | 1,605 |
| 2021 | 1 | — | 0 | 473 |
| 2022 | 1 | — | 0 | 153 |
| 2023 | 1 | — | 0 | 175 |
| 2024 | 0 | — | 0 | 257 |
| 2025 | 1 | — | 0 | 359 |
| 2026 | 0 | — | 2 (2) | — |
https://510kreport.com/device/K921766 · printed Nov 6, 2026
Cite this page
510(k) Report. “K921766: Ohio Infant Warmer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K921766
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026