510(k) · Cleared
ClearedThermochem HT-2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermasolutions, Inc. · MLW Warmer, Peritoneal Dialysate
Cleared on Oct 3, 2013 as substantially equivalent to K993330 (Hemocleanse, Inc., 1999) after a 125-day review. Its family tree reaches back 1 generation to 1999.
- Decided
- Oct 3, 2013
- Review
- 125 days
- Class
- Class II
- Product code
- MLW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K993330 (1999). No later device cites it as a predicate yet.
- Root · 1 generation backK993330 Thermochem-HT SystemHemocleanse, Inc. · 1999
- This deviceK131583 Thermochem HT-2000Thermasolutions, Inc. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K993330 | Thermochem-HT System | Hemocleanse, Inc. | 1999 | — |
| 0 (this device) | K131583 | Thermochem HT-2000 | Thermasolutions, Inc. | 2013 | — |
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 MLW? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K993330 | Thermochem-HT SystemSummary page 1…ual Warmer, Peritoneal Dialysate Name: Classification: 676.5630 Product Code: MVLW Predicate Device(s) ThermoChemn HT-1 000 System, K993330 K(13 1583… | 1999 |
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?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K993330.
How does its category compare?
All MLW devicesMLW Warmer, Peritoneal Dialysate: FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MLW
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MLW
Too few MLW 510(k)s in any year since 2007 to give a median.
Recalls per year · MLW
No recall names MLW since 2007.
Adverse event reports per year · MLW
2in 2025
MAUDE reports naming product code MLW, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 4 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 1 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The intended use of the ThermoChem HT-2000 System is to raise the care temperature of the peritoneum to a desired target temperature by continuously lavaging the peritoneum with circulating and warmed Lactated Ringer's Solution, U.S.P., or another physiologically compatible sterile solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131583 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131583: Thermochem HT-2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131583
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