510(k) · Cleared
Recalled · Class I · 2021Heiter 3000 Hyperthermic Perfusion System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hei, Inc. · LGZ Warmer, Thermal, Infusion Fluid
Cleared on Mar 21, 2012 as substantially equivalent to K092366 (Thermal Therapeutic Systems, Inc., 2010) and 1 other predicate after a 538-day review. Its family tree reaches back 3 generations to 1999. 1 of the 4 devices in its family, counting itself, has a Class I recall. It has been recalled once, including a Class I recall.
- Decided
- Mar 21, 2012
- Review
- 538 days
- Class
- Class II
- Product code
- LGZ
- Recalls
- 1 (1 Class I)
- Predicates
- 2
Its longest line of descent runs back 3 generations to K993330 (1999). No later device cites it as a predicate yet. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK993330 Thermochem-HT SystemHemocleanse, Inc. · 1999
- 2 generations backK070654 Hyperthermia PumpBelmont Instrument Corp. · 2007
- 1 generation backK092366 TTS100 Portable Hyperthermic Perfusion DeviceThermal Therapeutic Systems, Inc. · 2010
- This deviceK102900 Heiter 3000 Hyperthermic Perfusion SystemHei, Inc. · 2012
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K993330 | Thermochem-HT System | Hemocleanse, Inc. | 1999 | — |
| −2 | K070654 | Hyperthermia Pump | Belmont Instrument Corp. | 2007 | — |
| −1 | K092366 | TTS100 Portable Hyperthermic Perfusion Device | Thermal Therapeutic Systems, Inc. | 2010 | — |
| 0 (this device) | K102900 | Heiter 3000 Hyperthermic Perfusion System | Hei, Inc. | 2012 | — |
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 |
|---|---|---|---|
| * | K092366 | TTS100 Portable Hyperthermic Perfusion DeviceSummary page 1…lavaging the cavity with a sterile circulating, warmed, physiologically compatible solution such as sterile saline or Lactated Ringers. Predicate Devices K092366 TTS 100 Portable Hyperthermic Perfusion Device Thermal Therapeutic Systems, Inc K07065… | 2010 |
| * | K070654 | Hyperthermia PumpSummary page 1…ed Ringers. Predicate Devices K092366 TTS 100 Portable Hyperthermic Perfusion Device Thermal Therapeutic Systems, Inc K070654 Belmont Hyperthermia Pump Belmont Instruments Device Description The HElTER 3000 is compris… | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2021 | Class I | Z-2005-2021 | Device Design | The patient may be exposed to potential aluminum ion release during warming therapy under certain use conditions. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 13 years and passes through 4 companies; a new generation was cleared every 2.7 years on median.
- None of the 3 ancestors has a 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. 2012, 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 REITER 3000 Hyperthermnic Perfusion System is intended to raise the temperature of the thoracic or peritoneal cavity to a physician selected target temperature by continuously lavaging the cavity with a sterile circulating, warmed, physiologically compatible solution such as saline or Lactated Ringer's.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102900: Heiter 3000 Hyperthermic Perfusion System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102900
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