510(k) · Cleared
ClearedBiodex System 3 Model S3S-AP and Model S3D-3AP
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biodex Medical Systems, Inc. · IKK System, Isokinetic Testing And Evaluation
Cleared on Nov 16, 1995 as substantially equivalent to K915648 (Biodex Corp., 1992) and 2 other predicates after a 213-day review. Its family tree reaches back 1 generation to 1991. 1 later device descends from it.
- Decided
- Nov 16, 1995
- Review
- 213 days
- Class
- Class II
- Product code
- IKK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 1 generation to K905525 (1991). 3 ancestors in all. 1 later device descends from it, 1 citing it directly.
Most influential descendants
Showing 1 of 1 · See all- K123746Ames Therapy DeviceAmes Technology, Inc. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K905525 | CYBEX 6000 | Cybex | 1991 | — |
| 0 (this device) | K951770 | Biodex System 3 Model S3S-AP and Model S3D-3AP | Biodex Medical Systems, Inc. | 1995 | — |
| +1 | K123746 | Ames Therapy Device | Ames Technology, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 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 IKK? 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 |
|---|---|---|---|
| * | K915648 | Biodex System 2 Autoprogram | 1992 |
| * | K913021 | Biodex,Model B-2000Summary page 1…e is substantially equivalent to medical devices currently in commel ce, Oiodex System 2 Auto Program cleared via K-91 5648 and Biodex Clinical Data Station leafed via K-913021 and the Cybex 6000 cleared via K-905525.… | 1991 |
| * | K905525 | CYBEX 6000Summary page 1…devices currently in commel ce, Oiodex System 2 Auto Program cleared via K-91 5648 and Biodex Clinical Data Station leafed via K-913021 and the Cybex 6000 cleared via K-905525.… | 1991 |
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 |
|---|---|---|---|
| K123746 | Ames Therapy Device | 2013 | 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?
- None of the 3 ancestors has a recall.
- Of its descendants, K123746 (Ames Technology, Inc., 2013) has gone furthest, with 0 descendants of its own.
How does its category compare?
All IKK devicesIKK System, Isokinetic Testing And Evaluation: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · IKK
1in 2013
2026 to Oct 25, outlined.
Median 510(k) review, days · IKK
Too few IKK 510(k)s in any year since 2007 to give a median.
Recalls per year · IKK
1in 2013
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · IKK
2in 2024
MAUDE reports naming product code IKK, 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 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 2 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 1 |
| 2012 | 0 | — | 1 | 1 |
| 2013 | 1 | — | 1 | 3 |
| 2014 | 0 | — | 0 | 2 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 7 |
| 2017 | 0 | — | 0 | 2 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 1 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 3 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 0 | — | 0 | 2 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
This device is designed for physical therapy to exercise, measure, evaluate and increase the strength of muscles and increase the Range of Motion (ROM) of joints.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K951770 · printed Nov 6, 2026
Cite this page
510(k) Report. “K951770: Biodex System 3 Model S3S-AP and Model S3D-3AP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K951770
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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