510(k) · Cleared
Recalled · 2008Regenesis Model 42
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Regenesis Biomedical, Inc. · ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Cleared on Oct 21, 1997 as substantially equivalent to K903675 (Mrt, Inc., 1991) after a 139-day review. Its family tree reaches back 1 generation to 1991. It has been recalled once.
- Decided
- Oct 21, 1997
- Review
- 139 days
- Class
- Class II
- Product code
- ILX
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K903675 (1991). No later device cites it as a predicate yet.
- Root · 1 generation backK903675 Magnetic Resonance Therapy DeviceMrt, Inc. · 1991
- This deviceK972093 Regenesis Model 42Regenesis Biomedical, Inc. · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K903675 | Magnetic Resonance Therapy Device | Mrt, Inc. | 1991 | — |
| 0 (this device) | K972093 | Regenesis Model 42 | Regenesis Biomedical, Inc. | 1997 | — |
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 ILX? 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 ILX device
- #1 K241395 Active System; Avenue8score 9.4 · 4 generations · no Class I recall
What was it cleared against? (1)
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 |
|---|---|---|---|
| * | K903675 | Magnetic Resonance Therapy DeviceSummary page 5…1997 LEGALLY MARKETED PREDICATE DEVICES The Regenesis Model 42 is substantially equivalent to the MRT® sofPulse™ shortwave diathermy device made by ElectroPharmacology (K903675), which was cleared on January 17, 1991, DEVICE DESCRIPTION The Regenesis Model 42 device is a pulsed short-wave diathermy devi… | 1991 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 29, 2008 | Not classified | Z-0887-2009 | Finished device change control | In the course of device testing, the firm determined that the affected devices may, under certain unusual clinical circumstance, be unable to generate a therapeutic dose of radio frequency energy. As such, for these few devices, the… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Its one ancestor has no recall.
- 2 other devices also cite its predicate K903675.
How does its category compare?
All ILX devicesILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ILX
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · ILX
Too few ILX 510(k)s in any year since 2007 to give a median.
Recalls per year · ILX
1in 2008
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ILX
1in 2025
MAUDE reports naming product code ILX, 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 | 1 | — | 0 | 1 |
| 2008 | 1 | — | 1 | 2 |
| 2009 | 2 | — | 0 | 1 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 0 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 1 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The Regenesis Model 42 is indicated for adjunctive use in the palliative treatment of postoperative pain and edema in superficial soft tissue.
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/K972093 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972093: Regenesis Model 42.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972093
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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