510(k) · Cleared
ClearedWatch-Pat Model 100S-2
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 May 23, 2008 as substantially equivalent to K042916 (Itamar Medical, 2004) and 3 other predicates after a 98-day review. Its family tree reaches back 3 generations to 1991. 25 later devices descend from it.
- Decided
- May 23, 2008
- Review
- 98 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 3 generations to K910870 (1991). 14 ancestors in all, the oldest K830295 (1983). 25 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- 2 generations backK963597 Silent Night ILocal Silence, Inc. · 1997
- 1 generation backK981034 Silent Night IISleep Solutions, Inc. · 1998
- This deviceK080427 Watch-Pat Model 100S-2Itamar 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 |
|---|---|---|---|---|---|
| −3 | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| −2 | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| −1 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| 0 (this device) | K080427 | Watch-Pat Model 100S-2 | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 1998 | 1 | 0 |
| 2000 | 1 | 0 |
| 2004 | 1 | 0 |
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? (4)
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…5 3v 2725582 -087424/000001 -DC \\\ 5.11 Panel: Anesthesiology 5.12 Predicate Devices: * Watch-PatlOOS ("WP100S") (Itamar Ltd), cleared under K042916; product code MNR (ventilatory effort recorder). * BioSleep (Oxford BioSignal's Ltd.), cleared under K002622; pro… | 2004 |
| * | K002622 | BiosleepSummary page 2…tlOOS ("WP100S") (Itamar Ltd), cleared under K042916; product code MNR (ventilatory effort recorder). * BioSleep (Oxford BioSignal's Ltd.), cleared under K002622; product code GWQ (Electroencephalograph). * Silent night II (Sleep Solutions Inc.) cleared under K981034;… | 2000 |
| * | K981034 | Silent Night IISummary page 2…oSleep (Oxford BioSignal's Ltd.), cleared under K002622; product code GWQ (Electroencephalograph). * Silent night II (Sleep Solutions Inc.) cleared under K981034; product code MNR (ventilatory effort recorder). * Embla (Ferguson Medical) cleared under K971813, product code… | 1998 |
| * | K971813 | EMBLASummary page 2…Silent night II (Sleep Solutions Inc.) cleared under K981034; product code MNR (ventilatory effort recorder). * Embla (Ferguson Medical) cleared under K971813, product code GWQ (electroencephalograph) 5.12 Intended Use / Indication for Use: The Watch-PAT100S-2 (WP100S-2) devi… | 1998 |
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?
- The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 14 ancestors has a recall of any class.
- Of its descendants, K081982 (Itamar Medical, 2008) has gone furthest, with 24 descendants of its own.
- 2 other devices also cite its predicate K042916.
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-PATlOOS-2 (WP100S-2) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S-2 is a diagnostic aid for the detection of sleep related breathing disorders and sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake). The WP100S-2 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI") and…
Read the full statement (123 words)
The Watch-PATlOOS-2 (WP100S-2) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP100S-2 is a diagnostic aid for the detection of sleep related breathing disorders and sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake). The WP100S-2 generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI") and PAT sleep staging identification (PSTAGES). The WP100S-2's PSTAGES provides supplemental information to its PRDI/PAHI. The WP100S-2's PSTAGES 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-2 is not indicated for children less than 17 years old.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K080427 · printed Nov 3, 2026
Cite this page
510(k) Report. “K080427: Watch-Pat Model 100S-2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K080427
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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