Exo, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Exo, Inc.” (first 1983, latest 2025), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 103 days. Since 2017 the median was 110 days, against 144 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
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 | 2 | 105 |
| 2024 | 1 | 103 |
| 2025 | 1 | 196 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Exo, Inc. took a median 110 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 144 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QIH | Automated Radiological Image Processing Software | 3 | 3 |
| FIQ | Cannula, A-V Shunt | 1 | 1 |
| MYN | Analyzer, Medical Image | 1 | 1 |
Review panels
Most recent Exo, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K243239 | Lung AI (LAI001) | MYN | 2025-04-24 | 196 |
| K242359 | Strain AI (SAI001) | QIH | 2024-11-20 | 103 |
| K232501 | AI Platform (AIP001) | QIH | 2023-11-17 | 92 |
| K230497 | Bladder AI (AIBV01) | QIH | 2023-06-22 | 118 |
| K831801 | HEMOCLAV VENOUS CATHETER | FIQ | 1983-07-07 | 34 |
Recalls
openFDA lists no recalls under a recalling firm named Exo, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Exo, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Exo, Inc.” (first 1983, latest 2025), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Exo, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Exo, Inc. is 103 days. Since 2017: 110 days, versus 144 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Exo, Inc.?
The most frequent FDA product codes under this applicant name are QIH (Automated Radiological Image Processing Software, 3); FIQ (Cannula, A-V Shunt, 1); MYN (Analyzer, Medical Image, 1).
Next steps
- See all 5 Exo, Inc. clearances with predicates and recalls
- Run predicate analysis for product code QIH, Exo, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.