510(k) · Cleared
Recalled · Class II · 2014Infant Radiant Warmer - Models IW910 and IW920
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fisher & Paykel Electronics, Ltd. · FMT Warmer, Infant Radiant
Cleared on May 7, 1997 after a 92-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 323 later devices descend from it. It has been recalled 2 times.
- Decided
- May 7, 1997
- Review
- 92 days
- Class
- Class II
- Product code
- FMT
- Recalls
- 2
- Predicates
- 1
323 later devices descend from it, 1 citing it directly.
- This deviceK970432 Infant Radiant Warmer - Models IW910 and IW920Fisher & Paykel Electronics, Ltd. · 1997
- Descendant · cites it directly · 322 of its ownK982636 Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd. · 1998
- Descendant · 2 generations on · 295 of its ownK022609 Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003
- Descendant · 3 generations on · 294 of its ownK033768 Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004
- Descendant · 4 generations on · 241 of its ownK042165 Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · Recalled
- Descendant · 4 generations on · 239 of its ownK050370 Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005
Showing 5 of 323 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 323 · See all- K982636Patient Warmer- Model PW810Fisher & Paykel Healthcare, Ltd. · 1998 · cites it directly322descendants
- K022609Surgical Patient Warmer, Model PW820 JhuFisher & Paykel Healthcare, Ltd. · 2003 · 2 generations on295descendants
- K033768Altus Medical Optional Infrared HandpieceAltus Medical, Inc. · 2004 · 3 generations on294descendants
- K042165Cutera Tabletop Aesthetic ProductCutera, Inc. · 2004 · 4 generations on241descendants
- K050370Palomar Luxir HandpiecePalomar Medical Technologies, Inc. · 2005 · 4 generations on239descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970432 | Infant Radiant Warmer - Models IW910 and IW920 | Fisher & Paykel Electronics, Ltd. | 1997 | — |
| +1 | K982636 | Patient Warmer- Model PW810 | Fisher & Paykel Healthcare, Ltd. | 1998 | — |
| +2 | K022609 | Surgical Patient Warmer, Model PW820 Jhu | Fisher & Paykel Healthcare, Ltd. | 2003 | — |
| +3 | K033768 | Altus Medical Optional Infrared Handpiece | Altus Medical, Inc. | 2004 | — |
| +4 | K042165 | Cutera Tabletop Aesthetic Product | Cutera, Inc. | 2004 | 1 |
| +4 | K050370 | Palomar Luxir Handpiece | Palomar Medical Technologies, Inc. | 2005 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2005 | 4 | 0 |
| 2006 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 11 | 0 |
| 2009 | 4 | 0 |
| 2010 | 6 | 0 |
| 2011 | 5 | 0 |
| 2012 | 4 | 0 |
| 2013 | 4 | 0 |
| 2014 | 8 | 0 |
| 2015 | 14 | 0 |
| 2016 | 16 | 0 |
| 2017 | 12 | 0 |
| 2018 | 17 | 0 |
| 2019 | 17 | 0 |
| 2020 | 28 | 0 |
| 2021 | 22 | 0 |
| 2022 | 31 | 0 |
| 2023 | 21 | 0 |
| 2024 | 30 | 0 |
| 2025 | 38 | 0 |
| 2026 | 20 | 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.
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? (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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K921766 | FDA’s K921766 is Ohio Infant Warmer System Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree | 1993 |
What descends from it? (323)
See all 3231 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K982636 | Patient Warmer- Model PW810 | 1998 | 322 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 6, 2014 | Class II | Z-0210-2015 | Manufacturing material removal | Breakage of the nut that secures the heater head in place, which can cause the heater head to become partially detached and swing towards the bassinet. There is the potential that a heater head could contact a patient situated on the… |
| Oct 9, 2006 | Not classified | Z-0485-2007 | Other | This firm has received Product Complaint Reports concerning bending of the pivot plate. The elevator base of the CosyCot Infant Warmer incorporates a pivot plate which forms part of the mechanism allowing the CosyCot to raise and lower in… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K982636 (Fisher & Paykel Healthcare, Ltd., 1998) has gone furthest, with 322 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) | — |
What is it indicated for?
The intended use of Infant Radiant Warmers is to provide thermal support for newborn babies in the first few weeks of life This may include in the delivery room in the period immediately after birth, and in the neonatal intensive care unit for critically ill babies which may require frequent intervention from hospital personnel.
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/K970432 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970432: Infant Radiant Warmer - Models IW910 and IW920.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970432
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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