510(k) · Cleared
ClearedHTP-1500 Localized Heat Therapy Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Adroit Medical Systems, Inc. · ILO Pack, Hot Or Cold, Water Circulating
Cleared on Sep 10, 1997 after a 232-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Sep 10, 1997
- Review
- 232 days
- Class
- Class II
- Product code
- ILO
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK970197 HTP-1500 Localized Heat Therapy PumpAdroit Medical Systems, Inc. · 1997
- Descendant · cites it directly · 0 of its ownK073675 T-Pump Localized Temperature Therapy PumpGaymar Industries, Inc. · 2008 · Recalled
Most influential descendants
Showing 1 of 1 · See all- K073675T-Pump Localized Temperature Therapy PumpGaymar Industries, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970197 | HTP-1500 Localized Heat Therapy Pump | Adroit Medical Systems, Inc. | 1997 | — |
| +1 | K073675 | T-Pump Localized Temperature Therapy Pump | Gaymar Industries, Inc. | 2008 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 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.
Planning a device in ILO? 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 ILO device
- #1 K213097 Armory Motionscore 4.7 · 5 generations · no Class I recall
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 |
|---|---|---|---|
| * | — | MICRO-TEMP SMS-1000 Localized Heat Therapy Pump Named without a submission number | |
| * | — | MICRO-TEMP SMS-2000 Localized Heat Therapy Pump Named without a submission number |
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 |
|---|---|---|---|
| K073675 | T-Pump Localized Temperature Therapy Pump | 2008 | 0 |
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?
- Of its descendants, K073675 (Gaymar Industries, Inc., 2008) has gone furthest, with 0 descendants of its own.
How does its category compare?
All ILO devicesILO Pack, Hot Or Cold, Water Circulating: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ILO
1in 2022
2026 to Oct 25, outlined.
Median 510(k) review, days · ILO
Too few ILO 510(k)s in any year since 2007 to give a median.
Recalls per year · ILO
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILO
9in 2025
MAUDE reports naming product code ILO, 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 | 14 |
| 2008 | 1 | — | 0 | 12 |
| 2009 | 1 | — | 2 | 17 |
| 2010 | 0 | — | 0 | 171 |
| 2011 | 0 | — | 1 | 241 |
| 2012 | 0 | — | 0 | 65 |
| 2013 | 0 | — | 8 | 60 |
| 2014 | 0 | — | 0 | 49 |
| 2015 | 0 | — | 0 | 60 |
| 2016 | 0 | — | 0 | 44 |
| 2017 | 0 | — | 1 | 43 |
| 2018 | 0 | — | 0 | 40 |
| 2019 | 0 | — | 0 | 29 |
| 2020 | 0 | — | 0 | 7 |
| 2021 | 0 | — | 1 | 14 |
| 2022 | 1 | — | 0 | 10 |
| 2023 | 0 | — | 0 | 12 |
| 2024 | 0 | — | 0 | 10 |
| 2025 | 0 | — | 0 | 9 |
| 2026 | 0 | — | 4 | — |
What is it indicated for?
The HTP-1500 Localized Heat Therapy Pump is intended for use in those situations
where a physician determines that heat therapy is necessary or destrable.
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/K970197 · printed Nov 4, 2026
Cite this page
510(k) Report. “K970197: HTP-1500 Localized Heat Therapy Pump.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K970197
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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