510(k) · Cleared
Recalled · Class II · 2018Bio-Cal 370 Heater/Cooler
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bio Medicus, Inc. · DWJ System, Thermal Regulating
Cleared on Nov 2, 1989 after an 86-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 28 later devices descend from it. It has been recalled once.
- Decided
- Nov 2, 1989
- Review
- 86 days
- Class
- Class II
- Product code
- DWJ
- Recalls
- 1
- Predicates
- 0
28 later devices descend from it, 1 citing it directly.
- This deviceK894980 Bio-Cal 370 Heater/CoolerBio Medicus, Inc. · 1989
- Descendant · cites it directly · 27 of its ownK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
- Descendant · 2 generations on · 16 of its ownK022366 Celsius Control SystemInnercool Therapies · 2003
- Descendant · 2 generations on · 15 of its ownK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
- Descendant · 3 generations on · 8 of its ownK052443 Icy Catheter, Model IC-3893AAlsius Corp. · 2005
- Descendant · 4 generations on · 7 of its ownK070161 Quattro Catheter Model IC4593Alsius Corp. · 2007
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K012512Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002 · cites it directly27descendants
- K022366Celsius Control SystemInnercool Therapies · 2003 · 2 generations on16descendants
- K030421Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · 2 generations on15descendants
- K052443Icy Catheter, Model IC-3893AAlsius Corp. · 2005 · 3 generations on8descendants
- K070161Quattro Catheter Model IC4593Alsius Corp. · 2007 · 4 generations on7descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894980 | Bio-Cal 370 Heater/Cooler | Bio Medicus, Inc. | 1989 | — |
| +1 | K012512 | Setpoint Endovascular Temperature Management System | Radiant Medical | 2002 | — |
| +2 | K022366 | Celsius Control System | Innercool Therapies | 2003 | — |
| +2 | K030421 | Alsius Coolgard 3000 & Alsius Catheter System | Alsius Corp. | 2003 | 4 |
| +3 | K052443 | Icy Catheter, Model IC-3893A | Alsius Corp. | 2005 | — |
| +4 | K070161 | Quattro Catheter Model IC4593 | Alsius Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2003 | 4 | 0 |
| 2004 | 2 | 0 |
| 2005 | 2 | 0 |
| 2007 | 3 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 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 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (28)
See all 281 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012512 | Setpoint Endovascular Temperature Management System | 2002 | 27 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 8, 2018 | Class II | Z-0900-2018 | Device Design | Medtronic has been unable to develop a cleaning protocol to satisfy current industry concerns and expectations. As a result, an updated cleaning protocol will not be developed by Medtronic and it has been determined that the best course… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012512 (Radiant Medical, 2002) has gone furthest, with 27 descendants of its own.
How does its category compare?
All DWJ devicesDWJ System, Thermal Regulating: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K894980 · printed Nov 4, 2026
Cite this page
510(k) Report. “K894980: Bio-Cal 370 Heater/Cooler.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894980
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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