510(k) · Cleared
ClearedHeat Pain Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · NUH Stimulator, Nerve, Transcutaneous, Over-The-Counter
Cleared on Nov 9, 2018 as substantially equivalent to K160115 (Omron Healthcare, Inc., 2016) and 1 other predicate after a 106-day review. Its family tree reaches back 7 generations to 1994.
- Decided
- Nov 9, 2018
- Review
- 106 days
- Class
- Class II
- Product code
- NUH
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K940301 (1994). 13 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK940301 Compex 2Biodex Medical Systems, Inc. · 1994
- 6 generations backK011880 Compex SportCompex S.A. · 2002
- 5 generations backK060846 Therapeutic Massage CompanionEndurance Therapeutics · 2007
- 4 generations backK102598 HI-Dow-XPHi-Dow International, Inc. · 2011
- 3 generations backK121757 HealthmateforeverHealthmate International, LLC · 2012
- 2 generations backK141978 Maxpower ReliefOmron Healthcare, Inc. · 2014
- 1 generation backK160115 Heat Pain ProOmron Healthcare, Inc. · 2016
- This deviceK181992 Heat Pain ProOmron Healthcare, Inc. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K940301 | Compex 2 | Biodex Medical Systems, Inc. | 1994 | — |
| −6 | K011880 | Compex Sport | Compex S.A. | 2002 | — |
| −5 | K060846 | Therapeutic Massage Companion | Endurance Therapeutics | 2007 | — |
| −4 | K102598 | HI-Dow-XP | Hi-Dow International, Inc. | 2011 | — |
| −3 | K121757 | Healthmateforever | Healthmate International, LLC | 2012 | — |
| −2 | K141978 | Maxpower Relief | Omron Healthcare, Inc. | 2014 | — |
| −1 | K160115 | Heat Pain Pro | Omron Healthcare, Inc. | 2016 | — |
| 0 (this device) | K181992 | Heat Pain Pro | Omron Healthcare, Inc. | 2018 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2011 | 1 | 0 |
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 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 NUH? 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 NUH device
- #1 K190783 Health Expert Electronic Stimulator (model…score 15.8 · 7 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 |
|---|---|---|---|
| * | K160115 | Heat Pain ProSummary page 4…ulator, electrical, transcutaneous, for arthritis Class II Device Name: Heat Pain Pro Model PM311B Primary Predicate: K160115– Omron – Heat Pain Pro (Model PM311) Secondary Predicate: K172079 – Omron – Avail (PM601) Device Description: Th… | 2016 |
| * | K172079 | AvailSummary page 4…Heat Pain Pro Model PM311B Primary Predicate: K160115– Omron – Heat Pain Pro (Model PM311) Secondary Predicate: K172079 – Omron – Avail (PM601) Device Description: The Heat Pain Pro (PM311B) is a small battery operated OTC device that provides a co… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- The line of descent spans 24 years and passes through 6 companies; a new generation was cleared every 2.4 years on median.
- None of the 13 ancestors has a recall.
- 1 other device also cites its predicate K160115.
How does its category compare?
All NUH devicesNUH Stimulator, Nerve, Transcutaneous, Over-The-Counter: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · NUH
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · NUH
119in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · NUH
No recall names NUH since 2007.
Adverse event reports per year · NUH
7in 2025
MAUDE reports naming product code NUH, 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 | 4 | 161 | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 3 | 148 | 0 | 0 |
| 2011 | 6 | 231 | 0 | 0 |
| 2012 | 6 | 170 | 0 | 0 |
| 2013 | 10 | 189 | 0 | 1 |
| 2014 | 16 | 212 | 0 | 9 |
| 2015 | 14 | 198 | 0 | 11 |
| 2016 | 13 | 145 | 0 | 13 |
| 2017 | 17 | 155 | 0 | 21 |
| 2018 | 16 | 121 | 0 | 18 |
| 2019 | 19 | 213 | 0 | 5 |
| 2020 | 14 | 147 | 0 | 8 |
| 2021 | 14 | 198 | 0 | 7 |
| 2022 | 20 | 103 | 0 | 2 |
| 2023 | 15 | 127 | 0 | 4 |
| 2024 | 20 | 90 | 0 | 7 |
| 2025 | 15 | 119 | 0 | 7 |
| 2026 | 5 | 137 | 0 | — |
What is it indicated for?
The Omron Heat Pain Pro Model PM311B is intended for:
The relief of pain associated with sore or aching, muslces of the lower back, arm, legs, shoulder, or foot due to strain from exercise or normal household work activities.
When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Tap, Shoulder, Arm or Leg mode of stimulation.
Environment of Use: Clinics, hospital and home environments.
Patient Population: Adult
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/K181992 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181992: Heat Pain Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181992
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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