510(k) · Cleared
ClearedWatch Pat 100S
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 Dec 29, 2004 after a 69-day review. The FDA summary names its predicate without a number. 71 later devices descend from it.
- Decided
- Dec 29, 2004
- Review
- 69 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 0
71 later devices descend from it, 3 citing it directly.
- This deviceK042916 Watch Pat 100SItamar Medical · 2004
- Descendant · cites it directly · 43 of its ownK071230 Apnea Risk Evaluation System (Ares), Model 600Advanced Brain Monitoring, Inc. · 2007
- Descendant · 2 generations on · 41 of its ownK110705 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- Descendant · 3 generations on · 40 of its ownK111194 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011
- Descendant · 4 generations on · 38 of its ownK112514 Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012
- Descendant · cites it directly · 25 of its ownK081037 Watch-Pat 200I (WP200I)Itamar Medical · 2008
Showing 5 of 71 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 71 · See all- K071230Apnea Risk Evaluation System (Ares), Model 600Advanced Brain Monitoring, Inc. · 2007 · cites it directly43descendants
- K110705Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · 2 generations on41descendants
- K111194Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2011 · 3 generations on40descendants
- K112514Apnea Risk Evaluation System (Ares)Advanced Brain Monitoring, Inc. · 2012 · 4 generations on38descendants
- K081037Watch-Pat 200I (WP200I)Itamar Medical · 2008 · cites it directly25descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042916 | Watch Pat 100S | Itamar Medical | 2004 | — |
| +1 | K071230 | Apnea Risk Evaluation System (Ares), Model 600 | Advanced Brain Monitoring, Inc. | 2007 | — |
| +2 | K110705 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +3 | K111194 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2011 | — |
| +4 | K112514 | Apnea Risk Evaluation System (Ares) | Advanced Brain Monitoring, Inc. | 2012 | — |
| +1 | K081037 | Watch-Pat 200I (WP200I) | Itamar Medical | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 3 | 0 |
| 2011 | 4 | 0 |
| 2012 | 3 | 0 |
| 2013 | 3 | 0 |
| 2014 | 2 | 0 |
| 2015 | 3 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 2 | 0 |
| 2022 | 8 | 0 |
| 2023 | 6 | 0 |
| 2024 | 5 | 0 |
| 2025 | 7 | 0 |
| 2026 | 9 | 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? (2)
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 |
|---|---|---|---|
| * | — | Itamar's Watch PAT 100 (WP100) Named without a submission number | |
| * | — | Oxford BioSignal's BioSleep (BioSleep) Named without a submission number |
What descends from it? (71)
See all 713 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K071230 (Advanced Brain Monitoring, Inc., 2007) has gone furthest, with 43 descendants of its own.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years.
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 100S ("WP100S") device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S is a diagnostic aid for the detection of sleep related breathing disorders and rapid eye movement ("REM") sleep stages. The WP100S generates a peripheral arterial tonometry ("PAT") respiratory disturbance index ("PRDI") and PAT REM sleep stage identification ("PREM"). The WP100S's PREM provides…
Read the full statement (124 words)
The Watch-PAT 100S ("WP100S") device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S is a diagnostic aid for the detection of sleep related breathing disorders and rapid eye movement ("REM") sleep stages. The WP100S generates a peripheral arterial tonometry ("PAT") respiratory disturbance index ("PRDI") and PAT REM sleep stage identification ("PREM"). The WP100S's PREM provides supplemental information to its PRDI. The WP100S'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 WP100S is not indicated for children less than 17 years old. The WP100S is contraindicated for patients with latex allergy.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042916 · printed Nov 5, 2026
Cite this page
510(k) Report. “K042916: Watch Pat 100S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K042916
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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