510(k) · Cleared
ClearedTempedy
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Seiratherm GmbH · NCX System, Hypothermia, Intravenous, Cooling
Cleared on Sep 15, 2016 as substantially equivalent to K080899 (Medivance, Inc., 2008) and 2 other predicates after a 345-day review. Its family tree reaches back 6 generations to 1981. 4 of the 30 devices in its family, counting itself, have a Class I recall.
- Decided
- Sep 15, 2016
- Review
- 345 days
- Class
- Class II
- Product code
- NCX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K811742 (1981). 29 ancestors in all, the oldest K811743 (1981). No later device cites it as a predicate yet. 4 of the 30 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK811742 Hemotherm Model 400Cincinnati Sub-Zero · 1981 · Recalled
- 5 generations backK012512 Setpoint Endovascular Temperature Management SystemRadiant Medical · 2002
- 4 generations backK022366 Celsius Control SystemInnercool Therapies · 2003
- 3 generations backK030421 Alsius Coolgard 3000 & Alsius Catheter SystemAlsius Corp. · 2003 · Recalled
- 2 generations backK033623 Celsius Control SystemInnercool Therapies, Inc. · 2004
- 1 generation backK080908 Innercool Therapies, Inc., Rapidblue SystemInnercool Therapies, Inc.- A Delaware Corporation · 2008 · Recalled
- This deviceK152946 TempedySeiratherm GmbH · 2016
Class I recalls in this family
- K973741 Bair Hugger Blood/Fluid Warmer2 generations back · 1998
- K970864 Arrow-Howes Large Bore Multi-Lumen Central…4 generations back · 1997
- K895417 Arrow Large-Bore Dual Lumen Hemodialysis Kit5 generations back · 1990
- K862056 [Central Venous][Multi-Lumen] Catheter W/Flex Tip5 generations back · 1986
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K811742 | Hemotherm Model 400 | Cincinnati Sub-Zero | 1981 | 2 |
| −5 | K012512 | Setpoint Endovascular Temperature Management System | Radiant Medical | 2002 | — |
| −4 | K022366 | Celsius Control System | Innercool Therapies | 2003 | — |
| −3 | K030421 | Alsius Coolgard 3000 & Alsius Catheter System | Alsius Corp. | 2003 | 4 |
| −2 | K033623 | Celsius Control System | Innercool Therapies, Inc. | 2004 | — |
| −1 | K080908 | Innercool Therapies, Inc., Rapidblue System | Innercool Therapies, Inc.- A Delaware Corporation | 2008 | 1 |
| 0 (this device) | K152946 | Tempedy | Seiratherm GmbH | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1981 | 1 | 0 |
| 1982 | 1 | 0 |
| 1985 | 1 | 0 |
| 1986 | 1 | 1 |
| 1989 | 2 | 0 |
| 1990 | 2 | 1 |
| 1991 | 2 | 0 |
| 1993 | 1 | 0 |
| 1997 | 2 | 1 |
| 1998 | 1 | 1 |
| 2000 | 5 | 0 |
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2008 | 2 | 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.
4 devices in this family have a Class I recall. 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 NCX device
- #1 K213031 Solex 7 Intravascular Heat Exchange Catheter…score 10.9 · 9 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K080899 | Arctic Blast Intravenous Fluid ChillerSummary page 5…evices [21 CFR 807.92(a)(3)] The tempedy system uses similar technology and physical output characteristics as the following predicate devices: K080899 Artic Blast Intravenous Fluid Chiller (similar infusion of cold iv fluid to cool patient) from Medivance Inc.… | 2008 |
| * | K082217 | Ranger Rapid Flow Blood/Fluid Warming SystemSummary page 5…Intravenous Fluid Chiller (similar infusion of cold iv fluid to cool patient) from Medivance Inc. NCX Thermal regulating system K082217 Ranger Rapid Flow Blood/Fluid Warning System (similar infusion of warm iv fluid to warm the patient) from Arizant H… | 2008 |
| * | K080908 | Innercool Therapies, Inc., Rapidblue SystemSummary page 5…lood/Fluid Warning System (similar infusion of warm iv fluid to warm the patient) from Arizant Healthcare Inc. LGZ Unclassified K080908 RapidBlue System (similar patient temperature control of cooling or warming of the patient) from INNERCOOL Therapie… | 2008 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (4 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K973741Bair Hugger Blood/Fluid WarmerAugustine Medical, Inc. · 1998 · 2 generations back · ◆ in the 1998 ancestors bar of FIG. 11 Class I recall
- K970864Arrow-Howes Large Bore Multi-Lumen Central Venous CathetersArrow Intl., Inc. · 1997 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
- K895417Arrow Large-Bore Dual Lumen Hemodialysis KitArrow Intl., Inc. · 1990 · 5 generations back · ◆ in the 1990 ancestors bar of FIG. 11 Class I recall
- K862056[Central Venous][Multi-Lumen] Catheter W/Flex TipArrow Intl., Inc. · 1986 · 5 generations back · ◆ in the 1986 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 35 years and passes through 7 companies; a new generation was cleared every 4.4 years on median.
- 15 of the 29 ancestors have a recall of any class; 4 have a Class I recall.
- 1 other device also cites its predicate K080899.
How does its category compare?
All NCX devicesNCX System, Hypothermia, Intravenous, Cooling: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · NCX
1in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · NCX
204in 2016
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NCX
28in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · NCX
273in 2025
MAUDE reports naming product code NCX, 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 | 6 | 28 | 2 | 4 |
| 2008 | 3 | 129 | 0 | 8 |
| 2009 | 0 | — | 0 | 4 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 0 | — | 0 | 7 |
| 2012 | 0 | — | 0 | 14 |
| 2013 | 0 | — | 0 | 31 |
| 2014 | 1 | — | 1 | 41 |
| 2015 | 1 | — | 0 | 32 |
| 2016 | 3 | 204 | 0 | 311 |
| 2017 | 0 | — | 0 | 450 |
| 2018 | 0 | — | 0 | 509 |
| 2019 | 0 | — | 0 | 436 |
| 2020 | 0 | — | 0 | 415 |
| 2021 | 1 | — | 28 | 461 |
| 2022 | 1 | — | 0 | 511 |
| 2023 | 1 | — | 0 | 373 |
| 2024 | 0 | — | 0 | 343 |
| 2025 | 0 | — | 0 | 273 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Seiratherm GmbH tempedy 5000 is intended to deliver cooled or warmed sterile intravenous solutions which may be used to alter the body temperature of adult patients.
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/K152946 · printed Nov 6, 2026
Cite this page
510(k) Report. “K152946: Tempedy.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K152946
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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