510(k) · Cleared
ClearedWatchPAT400 (WP400)
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 Sep 5, 2025 as substantially equivalent to K223675 (Itamar Medical, Ltd., 2023) after a 199-day review. Its family tree reaches back 11 generations to 1992. 1 later device descends from it.
- Decided
- Sep 5, 2025
- Review
- 199 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to K913396 (1992). 52 ancestors in all, the oldest K830295 (1983). 1 later device descends from it, 1 citing it directly.
- Root · 11 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 7 generations between
- 3 generations backK180775 Watch-PAT300Itamar Medical, Ltd. · 2018
- 2 generations backK222331 WatchPAT300 (WP300)Itamar Medical, Ltd. · 2022
- 1 generation backK223675 WatchPAT ONE (WP1)Itamar Medical, Ltd. · 2023
- This deviceK250460 WatchPAT400 (WP400)Itamar Medical, Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK254042 WatchPAT SWItamar Medical, Ltd. · 2026
Show all 11 generations
- Root · 11 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 10 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 9 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 8 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 7 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 6 generations backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- 5 generations backK122516 Embletta MPREmbla Systems · 2013 · Recalled
- 4 generations backK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- 3 generations backK180775 Watch-PAT300Itamar Medical, Ltd. · 2018
- 2 generations backK222331 WatchPAT300 (WP300)Itamar Medical, Ltd. · 2022
- 1 generation backK223675 WatchPAT ONE (WP1)Itamar Medical, Ltd. · 2023
- This deviceK250460 WatchPAT400 (WP400)Itamar Medical, Ltd. · 2025
Most influential descendants
Showing 1 of 1 · See all- K254042WatchPAT SWItamar Medical, Ltd. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −10 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −9 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −8 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −7 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −6 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| −5 | K122516 | Embletta MPR | Embla Systems | 2013 | 1 |
| −4 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
| −3 | K180775 | Watch-PAT300 | Itamar Medical, Ltd. | 2018 | — |
| −2 | K222331 | WatchPAT300 (WP300) | Itamar Medical, Ltd. | 2022 | — |
| −1 | K223675 | WatchPAT ONE (WP1) | Itamar Medical, Ltd. | 2023 | — |
| 0 (this device) | K250460 | WatchPAT400 (WP400) | Itamar Medical, Ltd. | 2025 | — |
| +1 | K254042 | WatchPAT SW | Itamar Medical, Ltd. | 2026 | — |
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 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 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 |
|---|---|---|---|
| * | K223675 | WatchPAT ONE (WP1)Summary page 5…R Device Class: Class II Regulation Number: 868.2375 Panel: Anesthesiology Primary Predicate Device: WatchPAT ONE (WP1) Itamar Medical Ltd, K223675; product code MNR Reference Device: WatchPAT300 (WP300) Itamar Medical Ltd, K222331; product… | 2023 |
| † | K222331 | WatchPAT300 (WP300) | 2022 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K254042 | WatchPAT SW | 2026 | 0 |
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 33 years and passes through 8 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 52 ancestors have a recall of any class.
- Of its descendants, K254042 (Itamar Medical, Ltd., 2026) has gone furthest, with 0 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. 2025, 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 WatchPAT400 (WP400) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The device is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (REM Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP400 generates a peripheral arterial tonometry (“PAT”), Respiratory Disturbance Index ("pRDI"), Apnea-Hypopnea index ("pAHI"), Central…
Read the full statement (164 words)
The WatchPAT400 (WP400) is a non-invasive home care device for use with patients suspected to have sleep related breathing disorders. The device is a diagnostic aid for the detection of sleep related breathing disorders, sleep staging (REM Sleep, Light Sleep, Deep Sleep and Wake), snoring level and body position. The WP400 generates a peripheral arterial tonometry (“PAT”), Respiratory Disturbance Index ("pRDI"), Apnea-Hypopnea index ("pAHI"), Central Apnea-Hypopnea index ("pAHIc"), sleep staging identification (pSTAGES) and optional snoring level and body position discrete states from an external integrated snoring and body position sensor. The device’s pSTAGES and snoring level and body position provide supplemental information to its pRDI/pAHI/pAHIc. The device’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/K250460 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250460: WatchPAT400 (WP400).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K250460
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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