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 Oct 29, 2025 as substantially equivalent to K202359 (iRhythm Technologies, Inc., 2021) after a 219-day review. Its family tree reaches back 2 generations to 2012.
- Decided
- Oct 29, 2025
- Review
- 219 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K121319 (2012). No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
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 |
|---|---|---|---|
| * | K202359 | Zio MonitorSummary page 5…FR §868.2375 Regulatory Classification: Class 2 Product Code: MNR, BZQ, MWJ Predicate Device: iRhythm Zio Monitor (K202359) Reference Device: Huxley Medical SANSA HSAT (K244027) Device Description The Huxley Home Sleep Apnea Test (SANSATM) is… | 2021 |
| † | K244027 | Sansa Hsat | 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 13 years and passes through 2 companies; a new generation was cleared every 8.8 years on median.
- None of the 2 ancestors has a recall.
- 1 other device also cites its predicate K202359.
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 and cardiac 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). The system is prescription use only. The SANSA device records and stores ECG recording…
Read the full statement (124 words)
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 and
cardiac 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). The system is prescription use only.
The SANSA device records and stores ECG recording for up to 10 hours of wear time which can be
displayed in the software portal for manual annotation and analysis. The SANSA does not provide
automated analysis of the ECG and is not intended to be used with a 3rd party automated algorithm and is
not intended for pacemaker analysis.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K250882 · printed Nov 6, 2026
Cite this page
510(k) Report. “K250882: 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/K250882
Report an extraction error
Are you the manufacturer?
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