510(k) · Cleared
ClearedWatch-Pat 200I (WP200I)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Itamar Medical · MNR Ventilatory Effort Recorder
Cleared on Jun 9, 2008 as substantially equivalent to K042916 (Itamar Medical, 2004) after a 59-day review. Its family tree reaches back 1 generation to 2004. 25 later devices descend from it.
- Decided
- Jun 9, 2008
- Review
- 59 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K042916 (2004). 25 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK042916 Watch Pat 100SItamar Medical · 2004
- This deviceK081037 Watch-Pat 200I (WP200I)Itamar Medical · 2008
- Descendant · cites it directly · 24 of its ownK081982 Watch-Pat 200S-2 (WP200S-2)Itamar Medical · 2008
- Descendant · 2 generations on · 23 of its ownK102567 Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011
- Descendant · 3 generations on · 22 of its ownK133859 Watch-PAT200U (WP200U)Itamar Medical, Ltd. · 2014
- Descendant · 4 generations on · 20 of its ownK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- Descendant · 5 generations on · 12 of its ownK180775 Watch-PAT300Itamar Medical, Ltd. · 2018
Showing 5 of 25 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 25 · See all- K081982Watch-Pat 200S-2 (WP200S-2)Itamar Medical · 2008 · cites it directly24descendants
- K102567Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011 · 2 generations on23descendants
- K133859Watch-PAT200U (WP200U)Itamar Medical, Ltd. · 2014 · 3 generations on22descendants
- K161579Watch-PAT200UItamar Medical, Ltd. · 2017 · 4 generations on20descendants
- K180775Watch-PAT300Itamar Medical, Ltd. · 2018 · 5 generations on12descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K042916 | Watch Pat 100S | Itamar Medical | 2004 | — |
| 0 (this device) | K081037 | Watch-Pat 200I (WP200I) | Itamar Medical | 2008 | — |
| +1 | K081982 | Watch-Pat 200S-2 (WP200S-2) | Itamar Medical | 2008 | — |
| +2 | K102567 | Watch-Pat 200S-3 (WP200S-3) | Itamar Medical, Ltd. | 2011 | — |
| +3 | K133859 | Watch-PAT200U (WP200U) | Itamar Medical, Ltd. | 2014 | — |
| +4 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
| +5 | K180775 | Watch-PAT300 | Itamar Medical, Ltd. | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 4 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 6 | 0 |
| 2026 | 2 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MNR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MNR device
- #1 K244027 Sansa Hsatscore 18.1 · 12 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K042916 | Watch Pat 100SSummary page 2…r). Classification Name: Breathing Frequency Monitor Medical Specialty: Anesthesiology Predicate Devices: Watch-PatlOOS ("WPlO0S") (Itamar Ltd), cleared under K042916; product code MNR (ventilatory effort recorder). Device Description: The WATCH-PAT200i System (WP200i) is a non-… | 2004 |
What descends from it? (25)
See all 251 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081982 | Watch-Pat 200S-2 (WP200S-2) | 2008 | 24 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, this device’s year, is highlighted.
FDA decisions per year · MNR
10in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MNR
165in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MNR
1in 2021
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MNR
43in 2025
MAUDE reports naming product code MNR, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 6 | 124 | 2 | 1 |
| 2008 | 14 | 118 | 0 | 0 |
| 2009 | 8 | 89 | 1 | 0 |
| 2010 | 0 | — | 0 | 1 |
| 2011 | 9 | 90 | 1 | 1 |
| 2012 | 1 | — | 0 | 1 |
| 2013 | 4 | 161 | 0 | 0 |
| 2014 | 2 | — | 0 | 1 |
| 2015 | 4 | 229 | 0 | 4 |
| 2016 | 3 | 281 | 0 | 10 |
| 2017 | 4 | 275 | 0 | 4 |
| 2018 | 3 | 147 | 0 | 2 |
| 2019 | 8 | 383 | 0 | 3 |
| 2020 | 5 | 192 | 0 | 5 |
| 2021 | 3 | 137 | 1 | 5 |
| 2022 | 7 | 266 | 0 | 4 |
| 2023 | 6 | 183 | 0 | 13 |
| 2024 | 6 | 217 | 0 | 11 |
| 2025 | 10 | 165 | 0 | 43 |
| 2026 | 5 | 227 | 1 | — |
What is it indicated for?
The WATCH PAT TM 200i ("WP200i") is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200i is a diagnostic aid for the detection of sleep-related breathing disorders and rapid eye movement ("REM") sleep stages. The WP200i generates a peripheral arterial tonometry ("PAT"), respiratory disturbance index ("PRDI'), and PAT REM sleep stage identification ("PREM"). The WP200i's PREM provides…
Read the full statement (124 words)
The WATCH PAT TM 200i ("WP200i") is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200i is a diagnostic aid for the detection of sleep-related breathing disorders and rapid eye movement ("REM") sleep stages. The WP200i generates a peripheral arterial tonometry ("PAT"), respiratory disturbance index ("PRDI'), and PAT REM sleep stage identification ("PREM"). The WP200i's PREM provides supplemental information to its PRDI. The WP200i's PREM is not intended to be used as the sole or primary basis for diagnosing any sleep related breathing disorder, prescribing treatment, or determining whether additional diagnostic assessment is warranted.
The WP200i is not indicated for children less than 17 years old. The WP200i is contraindicated for patients with latex allergy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081037 · printed Nov 5, 2026
Cite this page
510(k) Report. “K081037: Watch-Pat 200I (WP200I).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K081037
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026