510(k) · Cleared
ClearedSnap Model 8 Snoring and Apnea Recording and Analysis System
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 Mar 18, 2011 as substantially equivalent to K080321 (Snap Laboratories, LLC, 2008) after a 67-day review. Its family tree reaches back 5 generations to 1995. 1 later device descends from it.
- Decided
- Mar 18, 2011
- Review
- 67 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K944524 (1995). 6 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backK944524 Snap Testing DeviceSnap Laboratories, LLC · 1995
- 4 generations backK971184 Oxi-SnapSnap Laboratories, LLC · 1997
- 3 generations backK984169 Digi-SnapSnap Laboratories, LLC · 1999
- 2 generations backK992322 Snap Model 5Snap Laboratories, LLC · 2000
- 1 generation backK080321 Snap Model 7 Snoring and Apnea Recording and Analysis SystemSnap Laboratories, LLC · 2008
- This deviceK110064 Snap Model 8 Snoring and Apnea Recording and Analysis SystemSnap Diagnostics, LLC · 2011
- Descendant · cites it directly · 0 of its ownK240100 SAM Model 9-10000Snap Diagnostics, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K240100SAM Model 9-10000Snap Diagnostics, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944524 | Snap Testing Device | Snap Laboratories, LLC | 1995 | — |
| −4 | K971184 | Oxi-Snap | Snap Laboratories, LLC | 1997 | — |
| −3 | K984169 | Digi-Snap | Snap Laboratories, LLC | 1999 | — |
| −2 | K992322 | Snap Model 5 | Snap Laboratories, LLC | 2000 | — |
| −1 | K080321 | Snap Model 7 Snoring and Apnea Recording and Analysis System | Snap Laboratories, LLC | 2008 | — |
| 0 (this device) | K110064 | Snap Model 8 Snoring and Apnea Recording and Analysis System | Snap Diagnostics, LLC | 2011 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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 |
|---|---|---|---|
| * | K080321 | Snap Model 7 Snoring and Apnea Recording and Analysis SystemSummary page 1…rding and Analysis System Common Name SNAP Model 8 Classification Name Ventilatory Effort Recorder (21 CIFR 868.2375, Product Code MNR) Predicate Device 510(k): K080321, SNAP MODEL 7 SNORING AND APNEA RECORDING AND ANALYSIS SYSTEM Special.510(k) -SNAP Model 8 Section 5… | 2008 |
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 |
|---|---|---|---|
| K240100 | SAM Model 9-10000 | 2024 | 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 16 years and passes through 2 companies; a new generation was cleared every 1.9 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K240100 (Snap Diagnostics, LLC, 2024) 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. 2011, 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 ModelS8 device is indicated for use in the diagnostic evaluation of patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.
The SNAP ModelS8 system is not intended as a substitute for full polysamnography 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K110064 · printed Nov 4, 2026
Cite this page
510(k) Report. “K110064: Snap Model 8 Snoring and Apnea Recording and Analysis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K110064
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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