510(k) · Cleared
ClearedHealth O Meter Electric Heating Pads Models EHP2, EHP3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sunbeam Health Division · IRT Pad, Heating, Powered
Cleared on Nov 27, 1996 as substantially equivalent to K924799 (Conair Corp., 1993) and 1 other predicate after a 173-day review. Its family tree reaches back 1 generation to 1993.
- Decided
- Nov 27, 1996
- Review
- 173 days
- Class
- Class II
- Product code
- IRT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K924799 (1993). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK924799 Moist Heat PadConair Corp. · 1993
- This deviceK962195 Health O Meter Electric Heating Pads Models EHP2, EHP3Sunbeam Health Division · 1996
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K924799 | Moist Heat Pad | Conair Corp. | 1993 | — |
| 0 (this device) | K962195 | Health O Meter Electric Heating Pads Models EHP2, EHP3 | Sunbeam Health Division | 1996 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 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 IRT? 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 IRT device
- #1 K250047 bite away twoscore 10.6 · 3 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (3)
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 |
|---|---|---|---|
| * | K924799 | Moist Heat PadSummary page 1…stantial Equivalence Claim: The Models EHP2 and EHP3 are substantially equivalent to the Jollowing models which are currently in distribution: 1. Conair Moist Heat Pad, K924799 2. Conair Moist Heat Pad with Automatic Shut-off, = K924800 3. Sunbeam / Walgreens Heating Pad none Substantial equivalence is c… | 1993 |
| * | K924800 | Mosist Heat Pad with Automatic OffSummary page 1…stantially equivalent to the Jollowing models which are currently in distribution: 1. Conair Moist Heat Pad, K924799 2. Conair Moist Heat Pad with Automatic Shut-off, = K924800 3. Sunbeam / Walgreens Heating Pad none Substantial equivalence is claimed because: the power source, manufacturing technology,… | 1993 |
| * | — | Sunbeam / Walgreens Heating Pad Named without a submission number |
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?
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K924799.
How does its category compare?
All IRT devicesIRT Pad, Heating, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IRT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IRT
Too few IRT 510(k)s in any year since 2007 to give a median.
Recalls per year · IRT
3in 2022
Class I (3 since 2007) Class II/III not classified
Adverse event reports per year · IRT
70in 2025
MAUDE reports naming product code IRT, 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 | 0 | — | 5 | 312 |
| 2008 | 1 | — | 0 | 242 |
| 2009 | 0 | — | 0 | 555 |
| 2010 | 0 | — | 0 | 413 |
| 2011 | 1 | — | 0 | 227 |
| 2012 | 0 | — | 0 | 233 |
| 2013 | 0 | — | 0 | 345 |
| 2014 | 1 | — | 0 | 414 |
| 2015 | 1 | — | 0 | 289 |
| 2016 | 1 | — | 1 | 182 |
| 2017 | 0 | — | 0 | 220 |
| 2018 | 0 | — | 0 | 325 |
| 2019 | 0 | — | 0 | 205 |
| 2020 | 0 | — | 0 | 117 |
| 2021 | 0 | — | 0 | 97 |
| 2022 | 1 | — | 3 (3) | 134 |
| 2023 | 0 | — | 0 | 321 |
| 2024 | 0 | — | 0 | 77 |
| 2025 | 1 | — | 0 | 70 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Use wherever hot applications are desirable for personal comfort, and wherever recommended by your physician, dentist or health care professional for the relief of minor muscular or joint pain.
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/K962195 · printed Nov 5, 2026
Cite this page
510(k) Report. “K962195: Health O Meter Electric Heating Pads Models EHP2, EHP3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K962195
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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