510(k) · Cleared
ClearedSansa Hsat
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Huxley Medical · MNR Ventilatory Effort Recorder
Cleared on Jan 28, 2025 as substantially equivalent to K240285 (Huxley Medical, 2024) after a 29-day review. Its family tree reaches back 12 generations to 1992. 2 later devices descend from it.
- Decided
- Jan 28, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K913396 (1992). 52 ancestors in all, the oldest K830295 (1983). 2 later devices descend from it, 2 citing it directly.
- Root · 12 generations backK913396 Cannula Style ThermocouplesPro-Tech, Inc. · 1992
- 8 generations between
- 3 generations backK183559 WatchPAT ONEItamar Medical, Ltd. · 2019
- 2 generations backK220095 ANNE SleepSibel, Inc. · 2022
- 1 generation backK240285 Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical · 2024
- This deviceK244027 Sansa HsatHuxley Medical · 2025
- Descendant · cites it directly · 0 of its ownK253148 RX-1 SleepVivaquant, Inc. Dba Rhythm Express · 2026
- Descendant · cites it directly · 0 of its ownK252497 Sansa HsatHuxley Medical · 2025
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 backK183559 WatchPAT ONEItamar Medical, Ltd. · 2019
- 2 generations backK220095 ANNE SleepSibel, Inc. · 2022
- 1 generation backK240285 Huxley SANSA Home Sleep Apnea Test (1000-00)Huxley Medical · 2024
- This deviceK244027 Sansa HsatHuxley Medical · 2025
Most influential descendants
Showing 2 of 2 · See allView 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 | K183559 | WatchPAT ONE | Itamar Medical, Ltd. | 2019 | — |
| −2 | K220095 | ANNE Sleep | Sibel, Inc. | 2022 | — |
| −1 | K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00) | Huxley Medical | 2024 | — |
| 0 (this device) | K244027 | Sansa Hsat | Huxley Medical | 2025 | — |
| +1 | K253148 | RX-1 Sleep | Vivaquant, Inc. Dba Rhythm Express | 2026 | — |
| +1 | K252497 | Sansa Hsat | Huxley Medical | 2025 | — |
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 |
|---|---|---|
| 2025 | 1 | 0 |
| 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 K250460 WatchPAT400 (WP400)score 16.0 · 11 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 |
|---|---|---|---|
| * | K240285 | Huxley SANSA Home Sleep Apnea Test (1000-00)Summary page 5…nitor Regulation: 21 CFR §868.2375 Regulatory Classification: Class 2 Product Code: MNR Predicate Device: SANSA HSAT (K240285) Device Description The Huxley Home Sleep Apnea Test (SANSATM) is a wearable device intended for use in the recording, analysis,… | 2024 |
What descends from it? (2)
2 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 33 years and passes through 10 companies; a new generation was cleared every 3.1 years on median.
- 4 of the 52 ancestors have a recall of any class.
- Of its descendants, K253148 (Vivaquant, Inc. Dba Rhythm Express, 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 Huxley Home Sleep Apnea Test (SANSA) is a wearable device intended for use in the recording, analysis, and storage of biophysical parameters to aid in the evaluation of sleep-related breathing disorders of adults suspected of sleep apnea. The device is intended for the clinical and home use setting under the direction of a Healthcare Professional (HCP).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K244027 · printed Nov 6, 2026
Cite this page
510(k) Report. “K244027: Sansa Hsat.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K244027
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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