510(k) · Cleared
Recalled · Class II · 2015Hydro-Temp Nicu and Skin Surface Temperature Senso
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deroyal Industries, Inc. · FMT Warmer, Infant Radiant
Cleared on Jan 31, 1994 after a 486-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it. It has been recalled once.
- Decided
- Jan 31, 1994
- Review
- 486 days
- Class
- Class II
- Product code
- FMT
- Recalls
- 1
- Predicates
- 0
9 later devices descend from it, 3 citing it directly.
- This deviceK925006 Hydro-Temp Nicu and Skin Surface Temperature SensoDeroyal Industries, Inc. · 1994
- Descendant · cites it directly · 6 of its ownK051873 Disposable Temperature, Skin and Esophageal ProbesGE Healthcare · 2005 · Recalled
- Descendant · 2 generations on · 5 of its ownK121999 General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013
- Descendant · 3 generations on · 2 of its ownK181967 Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018
- Descendant · 4 generations on · 1 of its ownK193338 Med-link Reusable Temperature Probes, Med-link Disposable…Shenzhen Med-Link Electronics Tech Co., Ltd. · 2020
- Descendant · 3 generations on · 1 of its ownK182755 Disposable Temperature ProbeShenzhen Caremed Medical Technology Co., Ltd. · 2018
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K051873Disposable Temperature, Skin and Esophageal ProbesGE Healthcare · 2005 · cites it directly6descendants
- K121999General Purpose Temperature Probe, Skin Temperature ProbeDraeger Medical GmbH · 2013 · 2 generations on5descendants
- K181967Disposable Temperature ProbeShenzhen Launch Electrical Co., Ltd. · 2018 · 3 generations on2descendants
- K193338Med-link Reusable Temperature Probes, Med-link Disposable Temperature ProbesShenzhen Med-Link Electronics Tech Co., Ltd. · 2020 · 4 generations on1descendant
- K182755Disposable Temperature ProbeShenzhen Caremed Medical Technology Co., Ltd. · 2018 · 3 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K925006 | Hydro-Temp Nicu and Skin Surface Temperature Senso | Deroyal Industries, Inc. | 1994 | — |
| +1 | K051873 | Disposable Temperature, Skin and Esophageal Probes | GE Healthcare | 2005 | 1 |
| +2 | K121999 | General Purpose Temperature Probe, Skin Temperature Probe | Draeger Medical GmbH | 2013 | — |
| +3 | K181967 | Disposable Temperature Probe | Shenzhen Launch Electrical Co., Ltd. | 2018 | — |
| +4 | K193338 | Med-link Reusable Temperature Probes, Med-link Disposable Temperature Probes | Shenzhen Med-Link Electronics Tech Co., Ltd. | 2020 | — |
| +3 | K182755 | Disposable Temperature Probe | Shenzhen Caremed Medical Technology Co., Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2013 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 4 | 0 |
| 2023 | 1 | 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? (9)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 14, 2015 | Class II | Z-0345-2016 | Process control | DeRoyal manufactured four lots of HNICU-32, Hydro-Temp(R) Neonatal Temperature Skin Sensor incorrectly. The pins contained in the probe were soldered incorrectly. When probe is connected to the proper port, this defect results in the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K051873 (GE Healthcare, 2005) has gone furthest, with 6 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/K925006 · printed Nov 3, 2026
Cite this page
510(k) Report. “K925006: Hydro-Temp Nicu and Skin Surface Temperature Senso.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K925006
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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