510(k) · Cleared
ClearedWatch-PAT200U
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Itamar Medical, Ltd. · MNR Ventilatory Effort Recorder
Cleared on Feb 24, 2017 as substantially equivalent to K133859 (Itamar Medical, Ltd., 2014) and 1 other predicate after a 262-day review. Its family tree reaches back 7 generations to 1992. 20 later devices descend from it.
- Decided
- Feb 24, 2017
- Review
- 262 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to K913396 (1992). 47 ancestors in all, the oldest K830295 (1983). 20 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 6 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 5 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 4 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 3 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 2 generations backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- 1 generation backK122516 Embletta MPREmbla Systems · 2013 · Recalled
- This deviceK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- Descendant · cites it directly · 12 of its ownK180775 Watch-PAT300Itamar Medical, Ltd. · 2018
- Descendant · cites it directly · 5 of its ownK191031 NightOwlEctosense NV · 2020
- Descendant · 2 generations on · 5 of its ownK183559 WatchPAT ONEItamar Medical, Ltd. · 2019
- Descendant · 3 generations on · 4 of its ownK220095 ANNE SleepSibel, Inc. · 2022
- Descendant · cites it directly · 4 of its ownK203839 WatchPAT200U (WP200U)Itamar Medical, Ltd. · 2022
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K180775Watch-PAT300Itamar Medical, Ltd. · 2018 · cites it directly12descendants
- K191031NightOwlEctosense NV · 2020 · cites it directly5descendants
- K183559WatchPAT ONEItamar Medical, Ltd. · 2019 · 2 generations on5descendants
- K220095ANNE SleepSibel, Inc. · 2022 · 3 generations on4descendants
- K203839WatchPAT200U (WP200U)Itamar Medical, Ltd. · 2022 · cites it directly4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −6 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −5 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −4 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −3 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −2 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| −1 | K122516 | Embletta MPR | Embla Systems | 2013 | 1 |
| 0 (this device) | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
| +1 | K180775 | Watch-PAT300 | Itamar Medical, Ltd. | 2018 | — |
| +1 | K191031 | NightOwl | Ectosense NV | 2020 | — |
| +2 | K183559 | WatchPAT ONE | Itamar Medical, Ltd. | 2019 | — |
| +3 | K220095 | ANNE Sleep | Sibel, Inc. | 2022 | — |
| +1 | K203839 | WatchPAT200U (WP200U) | Itamar Medical, Ltd. | 2022 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1986 | 1 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 3 | 0 |
| 1996 | 1 | 0 |
| 1997 | 2 | 0 |
| 1998 | 4 | 0 |
| 1999 | 2 | 0 |
| 2000 | 7 | 0 |
| 2001 | 2 | 0 |
| 2002 | 2 | 0 |
| 2003 | 3 | 0 |
| 2004 | 2 | 0 |
| 2008 | 3 | 0 |
| 2011 | 1 | 0 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K133859 | Watch-PAT200U (WP200U)Summary page 4…5.11 Panel: Anesthesiology 5.12 Predicate Devices: • Primary Predicate Device: Watch-PAT200U (“WP200U”) (Itamar Ltd), cleared under K133859; product code MNR (ventilatory effort recorder) • Additional Predicate Device: Embla Systems’ Embletta MPR Sleep Data Rec… | 2014 |
| * | K122516 | Embletta MPRSummary page 4…K133859; product code MNR (ventilatory effort recorder) • Additional Predicate Device: Embla Systems’ Embletta MPR Sleep Data Recording System (K122516) 5.13 Intended Use / Indication for Use: The Watch-PAT200U (WP200U) device is a non-invasive home care device for use with pati… | 2013 |
What descends from it? (20)
See all 203 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?
- The line of descent spans 25 years and passes through 8 companies; a new generation was cleared every 4.0 years on median.
- 4 of the 47 ancestors have a recall of any class.
- Of its descendants, K180775 (Itamar Medical, Ltd., 2018) has gone furthest, with 12 descendants of its own.
- 1 other device also cites its predicate K133859.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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-PAT200U (WP200U) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI")…
Read the full statement (169 words)
The Watch-PAT200U (WP200U) device is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The WP200U is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (Rapid Eye Movement (REM) Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP200U generates a peripheral arterial tonometry ("PAT") Respiratory Disturbance Index ("PRDI"), Apnea-Hypopnea index ("PAHI"), Central Apnea-Hypopnea index ("PAHIc"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The WP200U's PSTAGES and snoring level and body position provide supplemental information to its PRDI/PAHI/PAHIc. The WP200U's PSTAGES and snoring level and body position are 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.
PAHIc is indicated for use in patients 17 years and older. All other parameters are indicated for 12 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161579 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161579: Watch-PAT200U.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161579
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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