510(k) · Cleared
ClearedActive System; Avenue8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Caerus Corporation · ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Cleared on Dec 18, 2024 as substantially equivalent to K121702 (Orthocor Medical, 2013) and 2 other predicates after a 216-day review. Its family tree reaches back 4 generations to 1991.
- Decided
- Dec 18, 2024
- Review
- 216 days
- Class
- Class II
- Product code
- ILX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K903675 (1991). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK903675 Magnetic Resonance Therapy DeviceMrt, Inc. · 1991
- 3 generations backK070541 Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IIIvivi Technologies, Inc. · 2008
- 2 generations backK091996 Orthocor Knee System BasicOrthocor Medical · 2009
- 1 generation backK121702 Orthocor Active Device Orthocor General Use Active DeviceOrthocor Medical · 2013
- This deviceK241395 Active System; Avenue8Caerus Corporation · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K903675 | Magnetic Resonance Therapy Device | Mrt, Inc. | 1991 | — |
| −3 | K070541 | Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino II | Ivivi Technologies, Inc. | 2008 | — |
| −2 | K091996 | Orthocor Knee System Basic | Orthocor Medical | 2009 | — |
| −1 | K121702 | Orthocor Active Device Orthocor General Use Active Device | Orthocor Medical | 2013 | — |
| 0 (this device) | K241395 | Active System; Avenue8 | Caerus Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2020 | 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 ILX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K121702 | Orthocor Active Device Orthocor General Use Active DeviceSummary page 5…ILX - Shortwave Diathermy, For Use Other Than Applying Therapeutic Deep Heat IRT – Powered Heating Pad III. PREDICATE DEVICES Primary Predicate: K121702 – OrthoCor Active Device Secondary Predicate (Active System): K092044 – OrthoCor Knee Active System Secondary Predicate (Avenue8)… | 2013 |
| * | K092044 | Orthocor Knee System, Median, Large, X-LargeSummary page 5…ep Heat IRT – Powered Heating Pad III. PREDICATE DEVICES Primary Predicate: K121702 – OrthoCor Active Device Secondary Predicate (Active System): K092044 – OrthoCor Knee Active System Secondary Predicate (Avenue8): K202337 – HiDow Pulsed electromagnetic field wrap IV. DEVICE DES… | 2009 |
| * | K202337 | Pulsed electromagnetic field wrapSummary page 5…ATE DEVICES Primary Predicate: K121702 – OrthoCor Active Device Secondary Predicate (Active System): K092044 – OrthoCor Knee Active System Secondary Predicate (Avenue8): K202337 – HiDow Pulsed electromagnetic field wrap IV. DEVICE DESCRIPTION The Caerus Active System is a portable, compact, lightweight… | 2020 |
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 33 years and passes through 4 companies; a new generation was cleared every 11.6 years on median.
- None of the 6 ancestors has a recall.
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. 2024, this device’s year, is highlighted.
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 Active System and Avenue8 are indicated for adjunctive use in the temporary relief of pain, such as pain associated with over-exertion, strains, sprains, and arthritis.
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/K241395 · printed Nov 6, 2026
Cite this page
510(k) Report. “K241395: Active System; Avenue8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K241395
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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