510(k) · Cleared
ClearedStandex
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alt, Inc. · ION Exerciser, Non-Measuring
Cleared on May 1, 1989 after a 124-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- May 1, 1989
- Review
- 124 days
- Class
- Class I
- Product code
- ION
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 1 citing it directly.
- This deviceK885343 StandexAlt, Inc. · 1989
- Descendant · cites it directly · 6 of its ownK062402 Easystand EvolvInvacare Corp. · 2006
- Descendant · 2 generations on · 3 of its ownK071793 Convertible I-Series Positioning and Transfer ChairBarton Medical Corp. · 2007
- Descendant · 2 generations on · 1 of its ownK091242 BantamAltimate Medical, Inc. · 2009 · Recalled
- Descendant · 3 generations on · 1 of its ownK073565 Standard Wheelchair PlatformDesign Specific, Ltd. · 2009
- Descendant · 3 generations on · 0 of its ownK130517 EZ Transport ChairHarris Medical, LLC · 2014
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K062402Easystand EvolvInvacare Corp. · 2006 · cites it directly6descendants
- K071793Convertible I-Series Positioning and Transfer ChairBarton Medical Corp. · 2007 · 2 generations on3descendants
- K091242BantamAltimate Medical, Inc. · 2009 · 2 generations on1descendant
- K073565Standard Wheelchair PlatformDesign Specific, Ltd. · 2009 · 3 generations on1descendant
- K130517EZ Transport ChairHarris Medical, LLC · 2014 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K885343 | Standex | Alt, Inc. | 1989 | — |
| +1 | K062402 | Easystand Evolv | Invacare Corp. | 2006 | — |
| +2 | K071793 | Convertible I-Series Positioning and Transfer Chair | Barton Medical Corp. | 2007 | — |
| +2 | K091242 | Bantam | Altimate Medical, Inc. | 2009 | 1 |
| +3 | K073565 | Standard Wheelchair Platform | Design Specific, Ltd. | 2009 | — |
| +3 | K130517 | EZ Transport Chair | Harris Medical, LLC | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in ION? 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K062402 | Easystand Evolv | 2006 | 6 |
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, K062402 (Invacare Corp., 2006) has gone furthest, with 6 descendants of its own.
How does its category compare?
All ION devicesION Exerciser, Non-Measuring: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · ION
1in 2012
2026 to Oct 25, outlined.
Median 510(k) review, days · ION
Too few ION 510(k)s in any year since 2007 to give a median.
Recalls per year · ION
1in 2011
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · ION
2in 2025
MAUDE reports naming product code ION, 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 | 3 |
| 2008 | 0 | — | 0 | 1 |
| 2009 | 0 | — | 0 | 3 |
| 2010 | 0 | — | 0 | 3 |
| 2011 | 0 | — | 1 | 7 |
| 2012 | 1 | — | 0 | 4 |
| 2013 | 0 | — | 0 | 9 |
| 2014 | 0 | — | 0 | 5 |
| 2015 | 0 | — | 0 | 3 |
| 2016 | 0 | — | 0 | 6 |
| 2017 | 0 | — | 0 | 3 |
| 2018 | 0 | — | 0 | 5 |
| 2019 | 0 | — | 0 | 9 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 2 |
| 2024 | 0 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 2 |
| 2026 | 0 | — | 0 | — |
https://510kreport.com/device/K885343 · printed Nov 4, 2026
Cite this page
510(k) Report. “K885343: Standex.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K885343
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026