Cybex: FDA clearances and approvals
Cybex has 9 FDA 510(k) clearances (first 1984, latest 1995), across 3 product codes in 2 review panels. Median 510(k) review time: 98 days.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IKK | System, Isokinetic Testing And Evaluation | 7 | 7 |
| ISD | Exerciser, Measuring | 1 | 1 |
| KQX | Goniometer, Ac-Powered | 1 | 1 |
Review panels
- Physical Medicine (8)
- Neurology (1)
Most recent Cybex 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K950095 | CYBEX 770 | IKK | 1995-06-21 | 162 |
| K905525 | CYBEX 6000 | IKK | 1991-02-14 | 66 |
| K881681 | CYBEX BACK TESTING AND REHABILITATION SYSTEM | IKK | 1990-04-25 | 736 |
| K881676 | LINEAR LIFT DEVICE | IKK | 1990-04-25 | 736 |
| K894154 | METABOLIC SYSTEMS | ISD | 1989-10-24 | 132 |
| K873599 | EDI 320 | KQX | 1987-10-16 | 42 |
| K872911 | CYBEX 340 | IKK | 1987-09-24 | 62 |
| K844368 | LINEAR LIFT DEVICE | IKK | 1985-02-19 | 98 |
| K843739 | CYBEX TORSO TESTING & REHABILITATION | IKK | 1984-11-29 | 65 |
Recalls
openFDA lists no recalls under a recalling firm named Cybex.
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Cybex have?
Cybex has 9 FDA 510(k) clearances (first 1984, latest 1995), across 3 product codes in 2 review panels.
How long does FDA take to clear Cybex's 510(k)s?
The median time from FDA receipt to decision across Cybex's cleared 510(k)s is 98 days.
What devices does Cybex make?
Its most frequent FDA product codes are IKK (System, Isokinetic Testing And Evaluation, 7); ISD (Exerciser, Measuring, 1); KQX (Goniometer, Ac-Powered, 1).
Has Cybex had device recalls?
openFDA lists no recalls under a recalling firm name matching Cybex. Related entities may recall under other names.
Next steps
- See all 9 Cybex clearances with predicates and recalls
- Run predicate analysis for product code IKK, Cybex's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.