510(k) · Cleared
ClearedTTS100 Portable Hyperthermic Perfusion Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermal Therapeutic Systems, Inc. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Mar 4, 2010 as substantially equivalent to K993330 (Hemocleanse, Inc., 1999) and 1 other predicate after a 211-day review. Its family tree reaches back 2 generations to 1999. 1 of the 4 devices in its family, counting itself, has a Class I recall. 1 later device descends from it.
- Decided
- Mar 4, 2010
- Review
- 211 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K993330 (1999). 1 later device descends from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK993330 Thermochem-HT SystemHemocleanse, Inc. · 1999
- 1 generation backK070654 Hyperthermia PumpBelmont Instrument Corp. · 2007
- This deviceK092366 TTS100 Portable Hyperthermic Perfusion DeviceThermal Therapeutic Systems, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK102900 Heiter 3000 Hyperthermic Perfusion SystemHei, Inc. · 2012 · Recalled (Class I)
Class I recalls in this family
- K102900 Heiter 3000 Hyperthermic Perfusion Systemcites it directly · 2012
Most influential descendants
Showing 1 of 1 · See all- K102900Heiter 3000 Hyperthermic Perfusion SystemHei, Inc. · 2012 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K993330 | Thermochem-HT System | Hemocleanse, Inc. | 1999 | — |
| −1 | K070654 | Hyperthermia Pump | Belmont Instrument Corp. | 2007 | — |
| 0 (this device) | K092366 | TTS100 Portable Hyperthermic Perfusion Device | Thermal Therapeutic Systems, Inc. | 2010 | — |
| +1 | K102900 | Heiter 3000 Hyperthermic Perfusion System | Hei, Inc. | 2012 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2012 | 1 | 1 |
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.
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? (2)
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 2…Page 2 === K04 230, ThermalTherapeuticSystems, Inc. 3.0 21CFR 807.92(x)(3) 3.1 Predicate Device Information PreoicaTe DEVICES ' 510(k) DeviIcE 510(k) Sponsor Clehobal K993330 ThermoChem-HT System Hemocleanse, Inc. 12/30/1999 K070654 Belmont Hyperthermia Pump Belmont Instrument, Inc. 6/8/2007 4.0 21CFR 8… | 1999 |
| * | K070654 | Hyperthermia PumpSummary page 2…1CFR 807.92(x)(3) 3.1 Predicate Device Information PreoicaTe DEVICES ' 510(k) DeviIcE 510(k) Sponsor Clehobal K993330 ThermoChem-HT System Hemocleanse, Inc. 12/30/1999 K070654 Belmont Hyperthermia Pump Belmont Instrument, Inc. 6/8/2007 4.0 21CFR 807.92()(4) 4.1 Device Description The TTS100 Portable Hy… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K102900 | Heiter 3000 Hyperthermic Perfusion System Class I | 2012 | 0 |
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 · Cites it directly · ◆ in the 2012 descendants bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 7.4 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K102900 (Hei, Inc., 2012) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K993330.
How does its category compare?
All LGZ devicesLGZ Warmer, Thermal, Infusion Fluid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The intended use of the TTS100 Portable Hyperthermic Perfusion Device is to raise the temperature of the thoracic or peritoneal cavity to the desired target temperature by continuously lavaging the cavity with circulating, warmed, physiologically compatible sterile solution, according to a protocol to be selected by the physician.
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/K092366 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092366: TTS100 Portable Hyperthermic Perfusion Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092366
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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