510(k) · Cleared
ClearedThermochem-HT System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemocleanse, Inc. · MLW Warmer, Peritoneal Dialysate
Cleared on Dec 30, 1999 after an 87-day review. The FDA summary names no predicate by number. 1 of the 8 devices in its family, counting itself, has a Class I recall. 7 later devices descend from it.
- Decided
- Dec 30, 1999
- Review
- 87 days
- Class
- Class II
- Product code
- MLW
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly. 1 of the 8 devices in this family, counting this one, has a Class I recall.
- This deviceK993330 Thermochem-HT SystemHemocleanse, Inc. · 1999
- Descendant · cites it directly · 5 of its ownK070654 Hyperthermia PumpBelmont Instrument Corp. · 2007
- Descendant · 2 generations on · 1 of its ownK120026 Performer HT/ Hang&GO HT BasicRand S.R.L. · 2012
- Descendant · cites it directly · 1 of its ownK092366 TTS100 Portable Hyperthermic Perfusion DeviceThermal Therapeutic Systems, Inc. · 2010
- Descendant · 3 generations on · 0 of its ownK161613 Hang&Go PACRand S.R.L. · 2016 · Recalled
- Descendant · 2 generations on · 0 of its ownK152208 The Belmont Hyperthermia PumpBelmont Instrument Corporation · 2015 · Recalled
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K102900 Heiter 3000 Hyperthermic Perfusion System2 generations on · 2012
Most influential descendants
Showing 5 of 7 · See all- K070654Hyperthermia PumpBelmont Instrument Corp. · 2007 · cites it directly5descendants
- K120026Performer HT/ Hang&GO HT BasicRand S.R.L. · 2012 · 2 generations on1descendant
- K092366TTS100 Portable Hyperthermic Perfusion DeviceThermal Therapeutic Systems, Inc. · 2010 · cites it directly1descendant
- K161613Hang&Go PACRand S.R.L. · 2016 · 3 generations on0descendants
- K152208The Belmont Hyperthermia PumpBelmont Instrument Corporation · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K993330 | Thermochem-HT System | Hemocleanse, Inc. | 1999 | — |
| +1 | K070654 | Hyperthermia Pump | Belmont Instrument Corp. | 2007 | — |
| +2 | K120026 | Performer HT/ Hang&GO HT Basic | Rand S.R.L. | 2012 | — |
| +1 | K092366 | TTS100 Portable Hyperthermic Perfusion Device | Thermal Therapeutic Systems, Inc. | 2010 | — |
| +3 | K161613 | Hang&Go PAC | Rand S.R.L. | 2016 | 1 |
| +2 | K152208 | The Belmont Hyperthermia Pump | Belmont Instrument Corporation | 2015 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2010 | 1 | 0 |
| 2012 | 2 | 1 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 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.
1 device in this family has a Class I recall. 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?
The FDA summary names no predicate by number.
What descends from it? (7)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 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.
- K102900Heiter 3000 Hyperthermic Perfusion SystemHei, Inc. · 2012 · 2 generations on · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- Of its descendants, K070654 (Belmont Instrument Corp., 2007) has gone furthest, with 5 descendants of its own.
How does its category compare?
All MLW devicesMLW Warmer, Peritoneal Dialysate: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 System is to raise the core temperature of the peritoneum to the desired target temperature by continuously lavaging the peritoneum with circulating warmed Lactated Ringers’s Solution, U.S.P., or another physiologically compatible sterile solution.
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/K993330 · printed Nov 6, 2026
Cite this page
510(k) Report. “K993330: Thermochem-HT System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K993330
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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