Oxehealth Limited: FDA clearances and approvals
Oxehealth Limited has 5 FDA 510(k) clearances (first 2021, latest 2026), plus 1 De Novo decision, across 2 product codes in 2 review panels. Median 510(k) review time: 142 days. Since 2017 its median was 142 days, against 155 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2021 | 1 | 29 |
| 2022 | 1 | 32 |
| 2023 | 0 | — |
| 2024 | 1 | 142 |
| 2025 | 1 | 271 |
| 2026 | 1 | 290 |
Review time against the same product codes
Since 2017, Oxehealth Limited's cleared 510(k)s took a median 142 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 155 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| QME | Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate | 5 | 4 |
| LEL | Device, Sleep Assessment | 1 | 1 |
Review panels
- Cardiovascular (5)
- Neurology (1)
Most recent Oxehealth Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251200 | Vital Signs | QME | 2026-02-02 | 290 |
| K243687 | Vital Signs | QME | 2025-08-27 | 271 |
| K233618 | Oxevision Sleep Device | LEL | 2024-04-03 | 142 |
| K220899 | Oxehealth Vital Signs | QME | 2022-04-29 | 32 |
| K211906 | Vital Signs | QME | 2021-07-20 | 29 |
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN200019 | De Novo | Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate | 2021-03-26 |
Recalls
openFDA lists no recalls under a recalling firm named Oxehealth Limited.
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 Oxehealth Limited have?
Oxehealth Limited has 5 FDA 510(k) clearances (first 2021, latest 2026), plus 1 De Novo decision, across 2 product codes in 2 review panels.
How long does FDA take to clear Oxehealth Limited's 510(k)s?
The median time from FDA receipt to decision across Oxehealth Limited's cleared 510(k)s is 142 days. Since 2017: 142 days, versus 155 days for all cleared 510(k)s in the same product codes.
What devices does Oxehealth Limited make?
Its most frequent FDA product codes are QME (Software For Optical Camera-Based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/Or Respiratory Rate, 5); LEL (Device, Sleep Assessment, 1).
Has Oxehealth Limited had device recalls?
openFDA lists no recalls under a recalling firm name matching Oxehealth Limited. Related entities may recall under other names.
Next steps
- See all 5 Oxehealth Limited clearances with predicates and recalls
- Run predicate analysis for product code QME, Oxehealth Limited'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.