510(k) · Cleared
ClearedErgoselect/GE
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ergoline GmbH · ISD Exerciser, Measuring
Cleared on Oct 31, 2012 as substantially equivalent to K053078 (Ergoline GmbH, 2006) after a 464-day review. Its family tree reaches back 2 generations to 1985.
- Decided
- Oct 31, 2012
- Review
- 464 days
- Class
- Class II
- Product code
- ISD
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K851097 (1985). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 ISD? 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? (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 |
|---|---|---|---|
| * | K053078 | Ergoselect 100 K/P, Ergoselect 200 K/PSummary page 1…fication name: Measuring exerciser > 21 CER - 890.5360 Measuring exercise equipment Product Code: ISD Trade name: Ergoline Ergoselect / GE Predicate Device: K-number: K053078 Device name: Ergoselect 100 KIP; Ergoselect 200 K/P Firm: Ergoline GmbH Description of the Device: The Ergoselect is the resul… | 2006 |
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 27 years and passes through 2 companies; a new generation was cleared every 20.9 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All ISD devicesISD Exerciser, Measuring: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, this device’s year, is highlighted.
FDA decisions per year · ISD
1in 2020
2026 to Oct 25, outlined.
Median 510(k) review, days · ISD
Too few ISD 510(k)s in any year since 2007 to give a median.
Recalls per year · ISD
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ISD
2in 2025
MAUDE reports naming product code ISD, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 1 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 0 | — | 1 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 1 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 2 |
| 2019 | 1 | — | 0 | 1 |
| 2020 | 1 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Physiotherapy in redevelopment of muscles for restoration of motion to joints or for use as an adjunct treatment for obesity.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112121 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112121: Ergoselect/GE.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112121
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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