510(k) · Cleared
ClearedOrthocor Active Device Orthocor General Use Active Device
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Orthocor Medical · ILX Diathermy, Shortwave, For Use Other Than Applying Therapeutic Deep Heat
Cleared on May 6, 2013 as substantially equivalent to K091996 (Orthocor Medical, 2009) after a 332-day review. Its family tree reaches back 3 generations to 1991. 1 later device descends from it.
- Decided
- May 6, 2013
- Review
- 332 days
- Class
- Class II
- Product code
- ILX
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K903675 (1991). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK903675 Magnetic Resonance Therapy DeviceMrt, Inc. · 1991
- 2 generations backK070541 Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino IIIvivi Technologies, Inc. · 2008
- 1 generation backK091996 Orthocor Knee System BasicOrthocor Medical · 2009
- This deviceK121702 Orthocor Active Device Orthocor General Use Active DeviceOrthocor Medical · 2013
- Descendant · cites it directly · 0 of its ownK241395 Active System; Avenue8Caerus Corporation · 2024
Most influential descendants
Showing 1 of 1 · See all- K241395Active System; Avenue8Caerus Corporation · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K903675 | Magnetic Resonance Therapy Device | Mrt, Inc. | 1991 | — |
| −2 | K070541 | Ivivi Sofpulse, Models 912-M10, ROMA3 and Torino II | Ivivi Technologies, Inc. | 2008 | — |
| −1 | K091996 | Orthocor Knee System Basic | Orthocor Medical | 2009 | — |
| 0 (this device) | K121702 | Orthocor Active Device Orthocor General Use Active Device | Orthocor Medical | 2013 | — |
| +1 | K241395 | Active System; Avenue8 | Caerus Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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.
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 |
|---|---|---|---|
| * | K091996 | Orthocor Knee System BasicSummary page 5…n Name: Diathermy, Shorfwave, For Use Other Than Applying Therapeutic ' Deep Heat. De;vice Regulations: 21 CFR 890.5290(b) Class: I1I Product Code: ILX C) Predicate: K091996 — OrthoCor Active Knee System D) Device Description: The OrthoCor General Use Device (marketed as the OrthoCor Active Device) i… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241395 | Active System; Avenue8 | 2024 | 0 |
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 22 years and passes through 3 companies; a new generation was cleared every 3.4 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K241395 (Caerus Corporation, 2024) has gone furthest, with 0 descendants of its own.
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. 2013, 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 device 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/K121702 · printed Nov 4, 2026
Cite this page
510(k) Report. “K121702: Orthocor Active Device Orthocor General Use Active Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K121702
Report an extraction error
Are you the manufacturer?
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