Caire, Inc.: FDA clearances and approvals
Caire, Inc. has 7 FDA 510(k) clearances (first 1995, latest 2025), across 2 product codes in 1 review panel. Median 510(k) review time: 88 days. openFDA lists 12 product recalls by a recalling firm named Caire, Inc.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 120 |
| 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 | 1 | 128 |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, Caire, Inc.'s cleared 510(k)s took a median 128 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 224 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAW | Generator, Oxygen, Portable | 4 | 4 |
| BYJ | Unit, Liquid-Oxygen, Portable | 3 | 3 |
Review panels
- Anesthesiology (7)
Most recent Caire, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K250671 | FreeStyle Comfort (AS200 / FreeStyle Comfort) | CAW | 2025-07-11 | 128 |
| K120785 | OMNI 3 OXYGEN SYSTEM | CAW | 2012-10-25 | 224 |
| K121167 | CAIRE COMPANION 5 OXYGEN CONCENTRATOR | CAW | 2012-05-02 | 15 |
| K080023 | MODIFICATION TO: SPIRIT | BYJ | 2008-06-16 | 164 |
| K050153 | SPIRIT, MODEL HAS | BYJ | 2005-04-15 | 81 |
| K013251 | SPIRIT 300 | BYJ | 2001-12-18 | 81 |
| K952268 | MODEL DELTA, OM OXYGEN CONCENTRATOR | CAW | 1995-08-11 | 88 |
Recalls
12 product recalls in 6 recall events; 9 initiated in the last five years. Most recent: 2024-10-04.
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 Caire, Inc. have?
Caire, Inc. has 7 FDA 510(k) clearances (first 1995, latest 2025), across 2 product codes in 1 review panel.
How long does FDA take to clear Caire, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Caire, Inc.'s cleared 510(k)s is 88 days.
What devices does Caire, Inc. make?
Its most frequent FDA product codes are CAW (Generator, Oxygen, Portable, 4); BYJ (Unit, Liquid-Oxygen, Portable, 3).
Has Caire, Inc. had device recalls?
openFDA lists 12 product recalls in 6 recall events by a recalling firm whose name matches Caire, Inc; the most recent began 2024-10-04. Recall firm names are matched by name, so related entities filing under other names are not included.
Next steps
- See all 7 Caire, Inc. clearances with predicates and recalls
- Run predicate analysis for product code CAW, Caire, Inc.'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.