510(k) · Cleared
ClearedSAM Model 9-10000
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Snap Diagnostics, LLC · MNR Ventilatory Effort Recorder
Cleared on Jun 4, 2024 as substantially equivalent to K110064 (Snap Diagnostics, LLC, 2011) after a 144-day review. Its family tree reaches back 6 generations to 1995.
- Decided
- Jun 4, 2024
- Review
- 144 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K944524 (1995). 7 ancestors in all. No later device cites it as a predicate yet.
- Root · 6 generations backK944524 Snap Testing DeviceSnap Laboratories, LLC · 1995
- 5 generations backK971184 Oxi-SnapSnap Laboratories, LLC · 1997
- 4 generations backK984169 Digi-SnapSnap Laboratories, LLC · 1999
- 3 generations backK992322 Snap Model 5Snap Laboratories, LLC · 2000
- 2 generations backK080321 Snap Model 7 Snoring and Apnea Recording and Analysis SystemSnap Laboratories, LLC · 2008
- 1 generation backK110064 Snap Model 8 Snoring and Apnea Recording and Analysis SystemSnap Diagnostics, LLC · 2011
- This deviceK240100 SAM Model 9-10000Snap Diagnostics, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K944524 | Snap Testing Device | Snap Laboratories, LLC | 1995 | — |
| −5 | K971184 | Oxi-Snap | Snap Laboratories, LLC | 1997 | — |
| −4 | K984169 | Digi-Snap | Snap Laboratories, LLC | 1999 | — |
| −3 | K992322 | Snap Model 5 | Snap Laboratories, LLC | 2000 | — |
| −2 | K080321 | Snap Model 7 Snoring and Apnea Recording and Analysis System | Snap Laboratories, LLC | 2008 | — |
| −1 | K110064 | Snap Model 8 Snoring and Apnea Recording and Analysis System | Snap Diagnostics, LLC | 2011 | — |
| 0 (this device) | K240100 | SAM Model 9-10000 | Snap Diagnostics, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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 |
|---|---|---|---|
| * | K110064 | Snap Model 8 Snoring and Apnea Recording and Analysis SystemSummary page 5…Effort Recorder Regulation Number: 868.2375 Product Code: MNR Legally Marketed Predicate Device Predicate #: K110064 Predicate Trade Name: Snap Model 8 Product Code: MNR Intended Use/Indications for Use The SNA… | 2011 |
| † | K191088 | Checkme O2 Pulse Oximeter | 2019 |
| † | K102350 | Pulse Oximeter | 2010 |
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 29 years and passes through 2 companies; a new generation was cleared every 2.8 years on median.
- None of the 7 ancestors has a recall.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 SNAP Diagnostics SAM Model 9-10000 device is intended to record airflow, breathing effort and body position, and is indicated for use as an aid for diagnostic evaluation of patients for apnea and snoring. The SNAP Diagnostics SAM Model 9-10000 is not intended as a substitute for full polysomnography when additional parameters such as sleep stages or EEG activity are required. The target population consists of patients who are suspected of apnea…
Read the full statement (139 words)
The SNAP Diagnostics SAM Model 9-10000 device is intended to record airflow, breathing effort and body position, and is indicated for use as an aid for diagnostic evaluation of patients for apnea and snoring.
The SNAP Diagnostics SAM Model 9-10000 is not intended as a substitute for full polysomnography when additional parameters such as sleep stages or EEG activity are required.
The target population consists of patients who are suspected of apnea and/or complain about snoring. The majority of the test procedures will take place at the patient’s home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.
Use of this device must be under the direct supervision of a qualified adult (parent or guardian) or health care practitioner trained in the use of the Snap Diagnostics SAM Model 9-10000 device.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K240100 · printed Nov 6, 2026
Cite this page
510(k) Report. “K240100: SAM Model 9-10000.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K240100
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