510(k) · Cleared
ClearedThermostat 900 Administration Set, Model Ash 100, 200 and 300
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Paladin Biomedical Corporation · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Mar 20, 2008 after a 111-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below).
- Decided
- Mar 20, 2008
- Review
- 111 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 1
The summary cites one number, which could not be confirmed as its predicate (see the table below).
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 LGZ? 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 LGZ device
- #1 K260988 °M Warmer System with °M Stationscore 12.7 · 6 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K970045 | FDA’s K970045 is Solaro 33 The summary prints BK970045, a CBER number, which our reading took as K970045, FDA’s number for Solaro 33 (Metalor Dental USA Corp.). Its FDA name has none of the distinctive words the summary uses for the device it names, “ThermoStat 900 Blood & IV Fluid Adm. Set”. Kept off the family tree. Summary page 4…ce Name Proprietary Name: ThermoStat 900 Administration Set Common/Usual Name: warmer, thermal, infusion fluid Identification of Predicate or Legally Marketed Device BK970045 Microwave Medical System, 310-312 School St., Acton, MA 01720 Trade Name: ThermoStat 900 Blood & 1V Fluid Adm. Set Cleared Date:… | 1997 |
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.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · LGZ
2in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LGZ
546in 2022
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LGZ
1in 2016
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · LGZ
376in 2025
MAUDE reports naming product code LGZ, 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 | 11 |
| 2008 | 4 | 99 | 0 | 10 |
| 2009 | 2 | — | 1 | 12 |
| 2010 | 2 | — | 1 | 43 |
| 2011 | 3 | 77 | 8 | 54 |
| 2012 | 7 | 162 | 0 | 52 |
| 2013 | 5 | 143 | 0 | 16 |
| 2014 | 0 | — | 0 | 23 |
| 2015 | 2 | — | 1 | 34 |
| 2016 | 2 | — | 1 | 15 |
| 2017 | 2 | — | 0 | 58 |
| 2018 | 1 | — | 0 | 94 |
| 2019 | 3 | 209 | 0 | 340 |
| 2020 | 0 | — | 0 | 1,221 |
| 2021 | 0 | — | 0 | 885 |
| 2022 | 3 | 546 | 0 | 1,548 |
| 2023 | 1 | — | 0 | 1,033 |
| 2024 | 1 | — | 0 | 862 |
| 2025 | 2 | — | 0 | 376 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Paladin Biomedical Corporation ThermoStat 900 Administration Set is intended to be used with the MMS Thermostat 900 Blood and Fluid Warmer. The disposable cartridge and administration set is intended to deliver high volume, rapid administration of blood and physiological fluids when connected to a large bore catheter. The set is intended to help prevent hypothermia in patients receiving large volumes of fluids.
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/K073363 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073363: Thermostat 900 Administration Set, Model Ash 100, 200 and 300.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073363
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026