Medical device makerLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field. in IsraelLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field., part of Asahi KaseiLabelled by claude-haiku-5.5 from the firm's FDA names. It is not an FDA field.. FDA records under 2 spellings of its name, each linked to the record.
As of Nov 15, 2026, FDA's public records list Itamar Medical with 18 510(k) clearances. The most recent is a 510(k) clearance dated Oct 30, 2026: PolySense.
Drug approvals, 510(k) clearances, recalls and letters, 2017 to 2026 to date
A hatched bar is a year that is not over, so its count covers only part of the year.
| Oct 30, 2026 | PolySenseK260648 · GWL | 510(k) clearances |
| Jul 31, 2026 | WatchPAT SWK254042 · MNR | 510(k) clearances |
| Sep 5, 2025 | WatchPAT400 (WP400)K250460 · MNR | 510(k) clearances |
| Jan 6, 2023 | WatchPAT ONE (WP1)K223675 · MNR | 510(k) clearances |
| Dec 29, 2022 | EndoPATxK211557 · DQK | 510(k) clearances |
| Sep 14, 2022 | WatchPAT300 (WP300)K222331 · MNR | 510(k) clearances |
| Mar 21, 2022 | WatchPAT200U (WP200U)K203839 · MNR | 510(k) clearances |
| Jun 5, 2019 | WatchPAT ONEK183559 · MNR | 510(k) clearances |
Spellings are joined only when they reduce to the same name, or a reviewed source names the same company. Sharing an FDA establishment number (FEI) is not enough: contract sites make products for many firms. Facts marked AI were labelled by a language model from the firm's FDA names; everything else comes from FDA or Wikidata. How this page is built
