Itamar Medical , Ltd.: FDA clearances and approvals
Itamar Medical , Ltd. has 17 FDA 510(k) clearances (first 2003, latest 2026), across 2 product codes in 2 review panels. Median 510(k) review time: 162 days. Since 2017 its median was 199 days, against 138 days for all cleared 510(k)s in the same product codes.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 162 |
| 2015 | 0 | — |
| 2016 | 1 | 278 |
| 2017 | 1 | 262 |
| 2018 | 1 | 147 |
| 2019 | 1 | 167 |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 3 | 446 |
| 2023 | 1 | 30 |
| 2024 | 0 | — |
| 2025 | 1 | 199 |
| 2026 | 1 | 227 |
Review time against the same product codes
Since 2017, Itamar Medical , Ltd.'s cleared 510(k)s took a median 199 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 138 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| MNR | Ventilatory Effort Recorder | 15 | 15 |
| DQK | Computer, Diagnostic, Programmable | 2 | 2 |
Review panels
- Anesthesiology (15)
- Cardiovascular (2)
Most recent Itamar Medical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K254042 | WatchPAT SW | MNR | 2026-07-31 | 227 |
| K250460 | WatchPAT400 (WP400) | MNR | 2025-09-05 | 199 |
| K223675 | WatchPAT ONE (WP1) | MNR | 2023-01-06 | 30 |
| K211557 | EndoPATx | DQK | 2022-12-29 | 589 |
| K222331 | WatchPAT300 (WP300) | MNR | 2022-09-14 | 43 |
| K203839 | WatchPAT200U (WP200U) | MNR | 2022-03-21 | 446 |
| K183559 | WatchPAT ONE | MNR | 2019-06-05 | 167 |
| K180775 | Watch-PAT300 | MNR | 2018-08-17 | 147 |
| K161579 | Watch-PAT200U | MNR | 2017-02-24 | 262 |
| K153070 | Watch-PAT200U | MNR | 2016-07-26 | 278 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Itamar Medical , Ltd..
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 Itamar Medical , Ltd. have?
Itamar Medical , Ltd. has 17 FDA 510(k) clearances (first 2003, latest 2026), across 2 product codes in 2 review panels.
How long does FDA take to clear Itamar Medical , Ltd.'s 510(k)s?
The median time from FDA receipt to decision across Itamar Medical , Ltd.'s cleared 510(k)s is 162 days. Since 2017: 199 days, versus 138 days for all cleared 510(k)s in the same product codes.
What devices does Itamar Medical , Ltd. make?
Its most frequent FDA product codes are MNR (Ventilatory Effort Recorder, 15); DQK (Computer, Diagnostic, Programmable, 2).
Has Itamar Medical , Ltd. had device recalls?
openFDA lists no recalls under a recalling firm name matching Itamar Medical , Ltd. Related entities may recall under other names.
Next steps
- See all 17 Itamar Medical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code MNR, Itamar Medical , Ltd.'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.