510(k) · Cleared
ClearedCelsi Warmer
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hadleigh Health Technologies · DWJ System, Thermal Regulating
Cleared on Jun 20, 2025 as substantially equivalent to K152266 (Stryker Medical, 2016) after a 267-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Jun 20, 2025
- Review
- 267 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K912051 (1991). 11 ancestors in all, the oldest K811742 (1981). No later device cites it as a predicate yet.
- Root · 5 generations backK912051 Medi-Therm (Mta-5900) & Detachable HosesGaymar Industries, Inc. · 1991 · Recalled
- 4 generations backK061023 Thermosuit SystemLife Recovery Systems Hd, LLC · 2006 · Recalled
- 3 generations backK070112 Rapidcool Patient Temperature Management SystemMedcool, Inc. · 2007
- 2 generations backK100585 Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900Gaymar Industries, Inc. · 2011
- 1 generation backK152266 Altrix Precision Temperature Management SystemStryker Medical · 2016 · Recalled
- This deviceK242964 Celsi WarmerHadleigh Health Technologies · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K912051 | Medi-Therm (Mta-5900) & Detachable Hoses | Gaymar Industries, Inc. | 1991 | 2 |
| −4 | K061023 | Thermosuit System | Life Recovery Systems Hd, LLC | 2006 | 1 |
| −3 | K070112 | Rapidcool Patient Temperature Management System | Medcool, Inc. | 2007 | — |
| −2 | K100585 | Medi-Therm Hyper/Hypothermia System, Models MTA6900, MTA7900 | Gaymar Industries, Inc. | 2011 | — |
| −1 | K152266 | Altrix Precision Temperature Management System | Stryker Medical | 2016 | 1 |
| 0 (this device) | K242964 | Celsi Warmer | Hadleigh Health Technologies | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 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 DWJ? 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 DWJ device
- #1 K260278 ThermAffyx (TM) Patient Safety Systemscore 12.8 · 5 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 |
|---|---|---|---|
| * | K152266 | Altrix Precision Temperature Management SystemSummary page 5…cular PREDICATE DEVICE IDENTIFICATION The Celsi Warmer is substantially equivalent to the following predicate: 510(k) Number Predicate Device Name / Manufacturer K152266 Altrix Precision Temperature Management System / Stryker Medical DEVICE DESCRIPTIO… | 2016 |
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?
- The line of descent spans 34 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 8 of the 11 ancestors have a recall of any class.
- 2 other devices also cite its predicate K152266.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · DWJ
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DWJ
131in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DWJ
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DWJ
2,384in 2025
MAUDE reports naming product code DWJ, 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 | 4 | 106 | 0 | 52 |
| 2008 | 3 | 73 | 0 | 40 |
| 2009 | 3 | 106 | 6 | 71 |
| 2010 | 8 | 134 | 2 | 104 |
| 2011 | 4 | 180 | 7 | 136 |
| 2012 | 5 | 69 | 1 | 106 |
| 2013 | 5 | 77 | 2 | 73 |
| 2014 | 4 | 131 | 0 | 116 |
| 2015 | 0 | — | 1 | 245 |
| 2016 | 2 | — | 0 | 1,400 |
| 2017 | 5 | 153 | 3 | 1,473 |
| 2018 | 3 | 95 | 5 | 1,517 |
| 2019 | 2 | — | 3 | 2,294 |
| 2020 | 5 | 30 | 2 | 2,546 |
| 2021 | 2 | — | 1 | 2,689 |
| 2022 | 2 | — | 5 | 3,226 |
| 2023 | 6 | 42 | 0 | 3,455 |
| 2024 | 2 | — | 3 | 3,329 |
| 2025 | 3 | 131 | 0 | 2,384 |
| 2026 | 5 | 99 | 3 | — |
What is it indicated for?
Celsi Warmer is intended for use in hospitals under a clinician’s supervision or at their direction to assist nurses in continuous temperature monitoring and thermal treatment of neonates.
a. Maintain pre-set body temperature as determined by the physician.
b. Celsi Warmer is appropriate for neonates greater than 28 weeks gestational age who weigh between 1-4 kg.
c. Monitoring and controlling patient temperature.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K242964 · printed Nov 4, 2026
Cite this page
510(k) Report. “K242964: Celsi Warmer.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K242964
Report an extraction error
Are you the manufacturer?
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