510(k) · Cleared
ClearedSpace (TM) 7500
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
F.M. Wiest USA, Inc. · IKN Electromyograph, Diagnostic
Cleared on Jul 9, 1991 after a 60-day review. The FDA summary names no predicate by number. 1 later device descends from it.
- Decided
- Jul 9, 1991
- Review
- 60 days
- Class
- Class II
- Product code
- IKN
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK912071 Space (TM) 7500F.M. Wiest USA, Inc. · 1991
- Descendant · cites it directly · 0 of its ownK964522 Ellipse 4Andromeda Medizinische Systeme GmbH · 1997
Most influential descendants
Showing 1 of 1 · See all- K964522Ellipse 4Andromeda Medizinische Systeme GmbH · 1997 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K912071 | Space (TM) 7500 | F.M. Wiest USA, Inc. | 1991 | — |
| +1 | K964522 | Ellipse 4 | Andromeda Medizinische Systeme GmbH | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 IKN? 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?
The FDA summary names no predicate by number.
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 |
|---|---|---|---|
| K964522 | Ellipse 4 | 1997 | 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?
- Of its descendants, K964522 (Andromeda Medizinische Systeme GmbH, 1997) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IKN devicesIKN Electromyograph, Diagnostic: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IKN
3in 2017
2026 to Oct 25, outlined.
Median 510(k) review, days · IKN
188in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IKN
1in 2010
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IKN
3in 2025
MAUDE reports naming product code IKN, 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 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 2 |
| 2010 | 0 | — | 1 | 1 |
| 2011 | 2 | — | 0 | 4 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 2 | — | 0 | 24 |
| 2014 | 1 | — | 0 | 3 |
| 2015 | 1 | — | 0 | 13 |
| 2016 | 0 | — | 0 | 11 |
| 2017 | 3 | 188 | 0 | 2 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 6 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 2 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 3 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K912071 · printed Nov 6, 2026
Cite this page
510(k) Report. “K912071: Space (TM) 7500.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K912071
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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