510(k) · Cleared
ClearedServo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual Control Wall-Mount Cosycot Infant Warmer Model IW970
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 Oct 30, 1997 as substantially equivalent to K921766 (Ohmeda Medical, 1993) and 1 other predicate after an 86-day review. Its family tree reaches back 1 generation to 1989.
- Decided
- Oct 30, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- FMT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K892885 (1989). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK892885 Resubmitted RD1000 Neopuff Infant ResuscitatorFisher & Paykel Electronics, Ltd. · 1989
- This deviceK972885 Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual…Fisher & Paykel Electronics, Ltd. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K892885 | Resubmitted RD1000 Neopuff Infant Resuscitator | Fisher & Paykel Electronics, Ltd. | 1989 | — |
| 0 (this device) | K972885 | Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual Control… | Fisher & Paykel Electronics, Ltd. | 1997 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K921766 | Ohio Infant Warmer SystemSummary page 1…sification Name: Warmer, Infant Radiant - 80 FMT General Hospital Devices, 21 CFR §880.5130 (Class IlI) Predicate Devices: Ohmeda, Ohio Infant Warmer System, Model 3150, K921766 Fisher & Paykel, RD1000 Infant Resuscitator, K892885 This summary of 510(k) safety and effectiveness information is being submit… | 1993 |
| * | K892885 | Resubmitted RD1000 Neopuff Infant ResuscitatorSummary page 1…ral Hospital Devices, 21 CFR §880.5130 (Class IlI) Predicate Devices: Ohmeda, Ohio Infant Warmer System, Model 3150, K921766 Fisher & Paykel, RD1000 Infant Resuscitator, K892885 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990… | 1989 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K921766.
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 Fisher & Paykel Healthcare IW960 Servo-Control Wall-Mount CosyCot Infant Warmer and IW970 Manual-Control Wall-Mount CosyCot Infant Warmer are infant radiant warmers (as per 80 FMT, CFR §880.5130) containing an infrared heating element mounted above a built-in pediatric bed assembly, in order to maintain an infant's body temperature by means of controlled radiant heat. The IW960 and IW970 are designed to provide warmth to babies in the first few weeks…
Read the full statement (154 words)
The Fisher & Paykel Healthcare IW960 Servo-Control Wall-Mount CosyCot Infant Warmer and IW970 Manual-Control Wall-Mount CosyCot Infant Warmer are infant radiant warmers (as per 80 FMT, CFR §880.5130) containing an infrared heating element mounted above a built-in pediatric bed assembly, in order to maintain an infant's body temperature by means of controlled radiant heat.
The IW960 and IW970 are designed to provide warmth to babies in the first few weeks of life, when an infant's self-thermoregulation capacity may be reduced, or if external thermal support is required or desirable. This may include new-born babies in delivery room applications, including premature / low birth-weight infants, and support of critically ill babies in neonatal intensive care units (NICU's) or special care babv units (SCBLI's). Siteations which necessiteta unebstructed access to an infant, including during resuscitation or surgical procedures, may indicate ihe need for a radiant heat source instead of equivalent support devices such as infant incubators.
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/K972885 · printed Nov 5, 2026
Cite this page
510(k) Report. “K972885: Servo-Control Wall-Mount Cosycot Infant Warmer Model IW960, Manual Control Wall-Mount Cosycot Infant Warmer Model IW970.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K972885
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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