510(k) · Cleared
ClearedWatchPAT SW
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 31, 2026 as substantially equivalent to K250460 (Itamar Medical, Ltd., 2025) after a 227-day review. Its family tree reaches back 12 generations to 1992.
- Decided
- Jul 31, 2026
- Review
- 227 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K913396 (1992). 53 ancestors in all, the oldest K830295 (1983). No later device cites it as a predicate yet.
- Root · 12 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 8 generations between
- 3 generations backK222331 WatchPAT300 (WP300)Itamar Medical, Ltd. · 2022
- 2 generations backK223675 WatchPAT ONE (WP1)Itamar Medical, Ltd. · 2023
- 1 generation backK250460 WatchPAT400 (WP400)Itamar Medical, Ltd. · 2025
- This deviceK254042 WatchPAT SWItamar Medical, Ltd. · 2026
Show all 12 generations
- Root · 12 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 11 generations backK982293 Pressure Transducer Airflow SensorPro-Tech Services, Inc. · 1998
- 10 generations backK020607 Sleepflo, Model 101501Biomec, Inc. · 2002
- 9 generations backK030379 Aplab, Model 801D0030Sector Medical Corp. · 2003
- 8 generations backK041904 Compass F10 SystemMedcare Flaga · 2004
- 7 generations backK073682 Embletta GoldEmbla Systems, Inc. · 2008 · Recalled
- 6 generations backK122516 Embletta MPREmbla Systems · 2013 · Recalled
- 5 generations backK161579 Watch-PAT200UItamar Medical, Ltd. · 2017
- 4 generations backK180775 Watch-PAT300Itamar Medical, Ltd. · 2018
- 3 generations backK222331 WatchPAT300 (WP300)Itamar Medical, Ltd. · 2022
- 2 generations backK223675 WatchPAT ONE (WP1)Itamar Medical, Ltd. · 2023
- 1 generation backK250460 WatchPAT400 (WP400)Itamar Medical, Ltd. · 2025
- This deviceK254042 WatchPAT SWItamar Medical, Ltd. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K913396 | Cannula Style Thermocouples | Pro-Tech, Inc. | 1992 | — |
| −11 | K982293 | Pressure Transducer Airflow Sensor | Pro-Tech Services, Inc. | 1998 | — |
| −10 | K020607 | Sleepflo, Model 101501 | Biomec, Inc. | 2002 | — |
| −9 | K030379 | Aplab, Model 801D0030 | Sector Medical Corp. | 2003 | — |
| −8 | K041904 | Compass F10 System | Medcare Flaga | 2004 | — |
| −7 | K073682 | Embletta Gold | Embla Systems, Inc. | 2008 | 1 |
| −6 | K122516 | Embletta MPR | Embla Systems | 2013 | 1 |
| −5 | K161579 | Watch-PAT200U | Itamar Medical, Ltd. | 2017 | — |
| −4 | K180775 | Watch-PAT300 | Itamar Medical, Ltd. | 2018 | — |
| −3 | K222331 | WatchPAT300 (WP300) | Itamar Medical, Ltd. | 2022 | — |
| −2 | K223675 | WatchPAT ONE (WP1) | Itamar Medical, Ltd. | 2023 | — |
| −1 | K250460 | WatchPAT400 (WP400) | Itamar Medical, Ltd. | 2025 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K250460 | WatchPAT400 (WP400)Summary page 5…Recorder, MNR Device Class: Class II Regulation Number: 868.2375 Panel: Anesthesiology Predicate Device: Watch-PAT 400 (“WP400”) (Itamar Medical Ltd), cleared under K250460; product code MNR Reference Device: DeepRESP, NOX Medical, K252330 Purpose of the 510(k) notice ZOLL Itamar is introducing an u… | 2025 |
| † | K252330 | DeepRESP | 2025 |
| † | K241960 | DeepRESP | 2025 |
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 34 years and passes through 8 companies; a new generation was cleared every 3.9 years on median.
- 4 of the 53 ancestors have a recall of any class.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 WatchPAT SW analyzes data recorded by WatchPAT devices (WP300, WP1, WP400) and automatically generates respiratory indices, sleep stages, snoring level, and body position. WatchPAT SW is intended for use under the direction of a healthcare professional to aid in the diagnosis of obstructive and central sleep related breathing disorders. Central indices are indicated for use in patients 17 years and older. All other outputs are indicated for 12 years and older.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K254042 · printed Nov 5, 2026
Cite this page
510(k) Report. “K254042: WatchPAT SW.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K254042
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026