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 Jul 26, 2016 as substantially equivalent to K133859 (Itamar Medical, Ltd., 2014) after a 278-day review. Its family tree reaches back 7 generations to 1991.
- Decided
- Jul 26, 2016
- Review
- 278 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K910870 (1991). 20 ancestors in all, the oldest K830295 (1983). No later device cites it as a predicate yet.
- Root · 7 generations backK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- 6 generations backK963597 Silent Night ILocal Silence, Inc. · 1997
- 5 generations backK981034 Silent Night IISleep Solutions, Inc. · 1998
- 4 generations backK080427 Watch-Pat Model 100S-2Itamar Medical · 2008
- 3 generations backK081982 Watch-Pat 200S-2 (WP200S-2)Itamar Medical · 2008
- 2 generations backK102567 Watch-Pat 200S-3 (WP200S-3)Itamar Medical, Ltd. · 2011
- 1 generation backK133859 Watch-PAT200U (WP200U)Itamar Medical, Ltd. · 2014
- This deviceK153070 Watch-PAT200UItamar Medical, Ltd. · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| −6 | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| −5 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| −4 | K080427 | Watch-Pat Model 100S-2 | Itamar Medical | 2008 | — |
| −3 | K081982 | Watch-Pat 200S-2 (WP200S-2) | Itamar Medical | 2008 | — |
| −2 | K102567 | Watch-Pat 200S-3 (WP200S-3) | Itamar Medical, Ltd. | 2011 | — |
| −1 | K133859 | Watch-PAT200U (WP200U) | Itamar Medical, Ltd. | 2014 | — |
| 0 (this device) | K153070 | Watch-PAT200U | Itamar Medical, Ltd. | 2016 | — |
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 |
| 2002 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 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 |
|---|---|---|---|
| * | K133859 | Watch-PAT200U (WP200U)Summary page 4…nitor Regulation: Class II, 21 C.F.R. § 868.2375 Product Code: MNR Predicate Devices: Primary Predicate: Itamar Medical’s Watch-PAT200U (K133859) Reference Device: Embla Systems’ Embletta MPR Sleep Data Recording System (K122516) Indications for Use: The Watch-PAT… | 2014 |
| † | K122516 | Embletta MPR | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
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 5 companies; a new generation was cleared every 2.8 years on median.
- 1 of the 20 ancestors has a recall of any class.
- 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. 2016, 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 (151 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"), PAT sleep staging identification (PSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position (SBP) sensor. The WP200U's PSTAGES and SBP provide supplemental information to its PRDI/PAHI. The WP200U's PSTAGES and SBP 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.
The WP200U is indicated for use in patients 12 years of age or greater.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153070 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153070: 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/K153070
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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