510(k) · Cleared
ClearedOmron Massager Model HM-45
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Omron Healthcare, Inc. · ISA Massager, Therapeutic, Electric
Cleared on Mar 4, 1994 after a 112-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 403 later devices descend from it.
- Decided
- Mar 4, 1994
- Review
- 112 days
- Class
- Class I
- Product code
- ISA
- Recalls
- None
- Predicates
- 0
403 later devices descend from it, 1 citing it directly.
- This deviceK935459 Omron Massager Model HM-45Omron Healthcare, Inc. · 1994
- Descendant · cites it directly · 402 of its ownK042630 Revlight Skin Care SystemSkincare Technology, Inc. · 2005
- Descendant · 2 generations on · 266 of its ownK072564 Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008
- Descendant · 3 generations on · 198 of its ownK083899 Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009
- Descendant · 2 generations on · 129 of its ownK070388 Profile Multi-Platform SystemSciton, Inc · 2007
- Descendant · 2 generations on · 115 of its ownK060792 IllumimedPhotoactif, LLC · 2006
Showing 5 of 403 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 403 · See all- K042630Revlight Skin Care SystemSkincare Technology, Inc. · 2005 · cites it directly402descendants
- K072564Alma Lasers Harmony XL Multi-Application PlatformAlma Lasers, Ltd. · 2008 · 2 generations on266descendants
- K083899Revlite Q-Switched ND:Yag Laser SystemHoya Conbio, Inc. · 2009 · 3 generations on198descendants
- K070388Profile Multi-Platform SystemSciton, Inc · 2007 · 2 generations on129descendants
- K060792IllumimedPhotoactif, LLC · 2006 · 2 generations on115descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K935459 | Omron Massager Model HM-45 | Omron Healthcare, Inc. | 1994 | — |
| +1 | K042630 | Revlight Skin Care System | Skincare Technology, Inc. | 2005 | — |
| +2 | K072564 | Alma Lasers Harmony XL Multi-Application Platform | Alma Lasers, Ltd. | 2008 | — |
| +3 | K083899 | Revlite Q-Switched ND:Yag Laser System | Hoya Conbio, Inc. | 2009 | — |
| +2 | K070388 | Profile Multi-Platform System | Sciton, Inc | 2007 | — |
| +2 | K060792 | Illumimed | Photoactif, LLC | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 9 | 0 |
| 2009 | 5 | 0 |
| 2010 | 7 | 0 |
| 2011 | 4 | 0 |
| 2012 | 4 | 0 |
| 2013 | 6 | 0 |
| 2014 | 12 | 0 |
| 2015 | 14 | 0 |
| 2016 | 16 | 0 |
| 2017 | 21 | 0 |
| 2018 | 19 | 0 |
| 2019 | 13 | 0 |
| 2020 | 24 | 0 |
| 2021 | 26 | 0 |
| 2022 | 31 | 0 |
| 2023 | 28 | 0 |
| 2024 | 47 | 0 |
| 2025 | 69 | 0 |
| 2026 | 45 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ISA? 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 ISA device
- #1 K243488 Vmat Proscore 13.0 · 15 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (403)
See all 4031 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K042630 | Revlight Skin Care System | 2005 | 402 |
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, K042630 (Skincare Technology, Inc., 2005) has gone furthest, with 402 descendants of its own.
How does its category compare?
All ISA devicesISA Massager, Therapeutic, Electric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ISA
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ISA
Too few ISA 510(k)s in any year since 2007 to give a median.
Recalls per year · ISA
2in 2025
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ISA
16in 2025
MAUDE reports naming product code ISA, 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 | — | 0 | 2 |
| 2008 | 0 | — | 1 | 10 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 0 | — | 1 | 3 |
| 2012 | 0 | — | 0 | 2 |
| 2013 | 0 | — | 0 | 5 |
| 2014 | 0 | — | 0 | 6 |
| 2015 | 0 | — | 0 | 6 |
| 2016 | 0 | — | 0 | 12 |
| 2017 | 0 | — | 0 | 6 |
| 2018 | 2 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 1 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 8 |
| 2023 | 2 | — | 0 | 14 |
| 2024 | 1 | — | 0 | 13 |
| 2025 | 1 | — | 2 | 16 |
| 2026 | 0 | — | 1 | — |
https://510kreport.com/device/K935459 · printed Nov 4, 2026
Cite this page
510(k) Report. “K935459: Omron Massager Model HM-45.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K935459
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026