510(k) · Cleared
Recalled · Class III · 2017T-Pump Localized Temperature Therapy Pump
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Gaymar Industries, Inc. · ILO Pack, Hot Or Cold, Water Circulating
Cleared on May 8, 2008 as substantially equivalent to K760804 (Gaymar Industries, Inc., 1976) and 1 other predicate after a 132-day review. Its family tree reaches back 1 generation to 1976. It has been recalled once.
- Decided
- May 8, 2008
- Review
- 132 days
- Class
- Class II
- Product code
- ILO
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 1 generation to K760804 (1976). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK760804 T-Pump, Temperature - Therapy PumpGaymar Industries, Inc. · 1976
- This deviceK073675 T-Pump Localized Temperature Therapy PumpGaymar Industries, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K760804 | T-Pump, Temperature - Therapy Pump | Gaymar Industries, Inc. | 1976 | — |
| 0 (this device) | K073675 | T-Pump Localized Temperature Therapy Pump | Gaymar Industries, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K760804 | T-Pump, Temperature - Therapy PumpSummary page 1…, Water Circulating PREDICATE DEVICE Gaymar Industries, Inc. ("Gaymar") claims substantial equivalence to: 1. Gaymar Industries, Inc. T-Pump Temperature Therapy Pump (K760804) 2. Adroit Medical Systems, Inc, HTP-1 500 Localized Heat Therapy Pump (K970197) DEVICE DESCRIPTION The T-Pump Localized Tempe… | 1976 |
| * | K970197 | HTP-1500 Localized Heat Therapy PumpSummary page 1…s substantial equivalence to: 1. Gaymar Industries, Inc. T-Pump Temperature Therapy Pump (K760804) 2. Adroit Medical Systems, Inc, HTP-1 500 Localized Heat Therapy Pump (K970197) DEVICE DESCRIPTION The T-Pump Localized Temperature Therapy Pump is a small electronically controlled water heater that suppl… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 7, 2017 | Class III | Z-1013-2018 | Error in labeling | The T/Pump Operations Manual and Maintenance Manual were incorrectly revised to add the sentence, Temperature therapy can also be for heat conservation for normothermia maintenance to the Indications for Use statement. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- None of the 2 ancestors has a recall.
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. 2008, this device’s year, is highlighted.
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 T-Pump Localized Temperature Therapy Pump is intended for use in supplying warm or
cold water at controlled temperatures via water circulating pad for the application of localized
therapy in situations where a physician determines that temperature therapy is necessary or
desirable.
Localized temperature therapy is of particular benefit in treating the following: orthopedic
conditions such as acute injuries, chronic pain, lower back pain, muscle spasm and strains; skin
trauma such as abscesses, boils, bruises, bums and contusions; other medical conditions such as
chronic arthritis, neuritis, phlebitis, tendonitis and I.V. infiltration; and symptoms such as
infection and localized pain.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073675 · printed Nov 4, 2026
Cite this page
510(k) Report. “K073675: T-Pump Localized Temperature 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/K073675
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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