# Itamar Medical, Ltd.

- Location (FDA's records): Caesarea, IL
- FDA decisions: 17 (2003–2026): 17 510(k) clearances
- Names in FDA's records: Itamar Medical , Ltd. (12); Itamar Medical (5)
- Product codes: MNR (15), DQK (2)
- 510(k) review time since 2016: median 213 days, against 247 for FDA's reviews in the same codes and years (5 of 10 faster)
- Predicates its devices cite: 24 (17 its own); citations of its devices by later devices: 22 (17 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Ferguson Medical: 2 (https://510kreport.com/company/ferguson-medical)
- Embla Systems: 1 (https://510kreport.com/company/embla-systems)
- Oxford Biosignals Limited: 1 (https://510kreport.com/company/oxford-biosignals)
- Sleep Solutions, Inc.: 1 (https://510kreport.com/company/sleep-solutions)
- Itamar Medical (C.M.) 1997, Ltd.: 1 (https://510kreport.com/company/itamar-medical-cm-1997)
- Braebon Medical Corp.: 1 (https://510kreport.com/company/braebon-medical)

## Firms that cite its devices most
- Ectosense NV: 1 (https://510kreport.com/company/ectosense)
- Advanced Brain Monitoring, Inc.: 1 (https://510kreport.com/company/advanced-brain-monitoring)
- Sibel, Inc.: 1 (https://510kreport.com/company/sibel)
- Compumedics Limited: 1 (https://510kreport.com/company/compumedics)
- Endothelix, Inc.: 1 (https://510kreport.com/company/endothelix)

## Its most-cited devices
- K042916: Watch Pat 100S (2004), cited by 3
- K161579: Watch-PAT200U (2017), cited by 3
- K180775: Watch-PAT300 (2018), cited by 3
- K133859: Watch-PAT200U (WP200U) (2014), cited by 2
- K032519: Endo Pat 2000 (2003), cited by 2
- K081037: Watch-Pat 200I (WP200I) (2008), cited by 1

## Recent decisions
- K254042: WatchPAT SW (Jul 31, 2026)
- K250460: WatchPAT400 (WP400) (Sep 5, 2025)
- K223675: WatchPAT ONE (WP1) (Jan 6, 2023)
- K211557: EndoPATx (Dec 29, 2022)
- K222331: WatchPAT300 (WP300) (Sep 14, 2022)
- K203839: WatchPAT200U (WP200U) (Mar 21, 2022)
- K183559: WatchPAT ONE (Jun 5, 2019)
- K180775: Watch-PAT300 (Aug 17, 2018)

Source page: https://510kreport.com/company/itamar-medical