# K970197: HTP-1500 Localized Heat Therapy Pump

- Pathway: 510(k) (Traditional)
- Applicant: Adroit Medical Systems, Inc.
- Decided: Sep 10, 1997 after 232 days
- Product code: ILO (Pack, Hot Or Cold, Water Circulating)
- Device class: 2
- Regulation: 21 CFR 890.5720
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) MICRO-TEMP SMS-1000 Localized Heat Therapy Pump: named in the summary without a submission number
- (no number) MICRO-TEMP SMS-2000 Localized Heat Therapy Pump: named in the summary without a submission number

## Most influential descendants
- K073675: T-Pump Localized Temperature Therapy Pump (2008), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K970197
Methodology: https://510kreport.com/methodology