510(k) · Cleared
ClearedBio-Mat 2000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Richway Intl., Inc. · IRT Pad, Heating, Powered
Cleared on Feb 8, 2008 after a 154-day review. The FDA summary names its predicate without a number. 5 later devices descend from it.
- Decided
- Feb 8, 2008
- Review
- 154 days
- Class
- Class II
- Product code
- IRT
- Recalls
- None
- Predicates
- 0
5 later devices descend from it, 2 citing it directly.
- This deviceK072534 Bio-Mat 2000Richway Intl., Inc. · 2008
- Descendant · cites it directly · 4 of its ownK092589 Thermotex Platinum SystemEas Consulting Group, LLC · 2010
- Descendant · 2 generations on · 1 of its ownK111273 Fir Heat Theraphy SysyemsShenzhen Anpan Technology Co., Ltd. · 2011
- Descendant · 3 generations on · 0 of its ownK133981 Avacen 100Avacen, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK120254 Therasage Heating PadTherasage Corporation · 2012
- Descendant · 2 generations on · 0 of its ownK101227 Back-TekYork Biomedical, Inc. · 2010
Most influential descendants
Showing 5 of 5 · See all- K092589Thermotex Platinum SystemEas Consulting Group, LLC · 2010 · cites it directly4descendants
- K111273Fir Heat Theraphy SysyemsShenzhen Anpan Technology Co., Ltd. · 2011 · 2 generations on1descendant
- K133981Avacen 100Avacen, Inc. · 2014 · 3 generations on0descendants
- K120254Therasage Heating PadTherasage Corporation · 2012 · cites it directly0descendants
- K101227Back-TekYork Biomedical, Inc. · 2010 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K072534 | Bio-Mat 2000 | Richway Intl., Inc. | 2008 | — |
| +1 | K092589 | Thermotex Platinum System | Eas Consulting Group, LLC | 2010 | — |
| +2 | K111273 | Fir Heat Theraphy Sysyems | Shenzhen Anpan Technology Co., Ltd. | 2011 | — |
| +3 | K133981 | Avacen 100 | Avacen, Inc. | 2014 | — |
| +1 | K120254 | Therasage Heating Pad | Therasage Corporation | 2012 | — |
| +2 | K101227 | Back-Tek | York Biomedical, Inc. | 2010 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2014 | 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? (6)
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 |
|---|---|---|---|
| * | — | Chung Cheng Electric Far Infrared Healthful Lamp Named without a submission number | |
| * | — | Lightwave Infrared Lamp Named without a submission number | |
| * | — | LumiWave lx4 Infrared Therapy Device Named without a submission number | |
| * | — | AutoPrism Infrared Lamp Named without a submission number | |
| * | — | KenkoWave Infrared Pain Treatment System Named without a submission number | |
| * | — | Health O Meter Electric Heating Pad with Massage Named without a submission number |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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, K092589 (Eas Consulting Group, LLC, 2010) has gone furthest, with 4 descendants of its own.
How does its category compare?
All IRT devicesIRT Pad, Heating, Powered: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
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?
The Bio-Mat is indicated for the temporary relief of minor muscle and joint pain and stiffness; the temporary relief of joint pain associated with arthritis; the temporary relief of muscle spasms, minor sprains and strains, and minor muscular back pain; the relaxation of muscles; and the temporary increase of local circulation where applied.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072534 · printed Nov 5, 2026
Cite this page
510(k) Report. “K072534: Bio-Mat 2000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K072534
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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