510(k) · Cleared
Recalled · Class II · 2014Servo-Control Wall-Mount Infant Warmer (IW980)/Manual-Control Wall-Mount Infant Warmer (IW990)
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 Jul 16, 1997 as substantially equivalent to K921766 (Ohmeda Medical, 1993) after an 86-day review. Its family tree reaches back 1 generation to 1993. It has been recalled once.
- Decided
- Jul 16, 1997
- Review
- 86 days
- Class
- Class II
- Product code
- FMT
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921766 (1993). No later device cites it as a predicate yet.
- Root · 1 generation backK921766 Ohio Infant Warmer SystemOhmeda Medical · 1993 · Recalled
- This deviceK971461 Servo-Control Wall-Mount Infant Warmer (IW980)/Manual-Control…Fisher & Paykel Electronics, Ltd. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921766 | Ohio Infant Warmer System | Ohmeda Medical | 1993 | 1 |
| 0 (this device) | K971461 | Servo-Control Wall-Mount Infant Warmer (IW980)/Manual-Control Wall-Mount… | Fisher & Paykel Electronics, Ltd. | 1997 | — |
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.
| 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 lil) Predicate Device: Ohmeda, Ohio Infant Warmer System, Model 3050, K921766 This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has a recall.
- 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 IW980 Servo-Control Wall-Mount Infant Warmer and IW990 Manual-Control Wall-Mount Infant Warmer are infant radiant warmers (as per 80 FMT, CFR §880.5130) containing an infrared heating element intended to be mounted over an infant in a pediatric hospital bed, to maintain the infant's body temperature by means of controlled radiant heat. The IWS980 and IW9S0 are designed to provide warmth to babies in the first few weeks of…
Read the full statement (155 words)
The Fisher & Paykel Healthcare IW980 Servo-Control Wall-Mount Infant Warmer and IW990 Manual-Control Wall-Mount Infant Warmer are infant radiant warmers (as per 80 FMT, CFR §880.5130) containing an infrared heating element intended to be mounted over an infant in a pediatric hospital bed, to maintain the infant's body temperature by means of controlled radiant heat.
The IWS980 and IW9S0 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 baby units (SCBU's). Situations which necessitate unobstructed access to an infant, including during resuscitation or surgical procedures, may indicate the 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/K971461 · printed Nov 5, 2026
Cite this page
510(k) Report. “K971461: Servo-Control Wall-Mount Infant Warmer (IW980)/Manual-Control Wall-Mount Infant Warmer (IW990).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K971461
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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