510(k) · Cleared
ClearedDigi-Snap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Snap Laboratories, LLC · MNR Ventilatory Effort Recorder
Cleared on May 26, 1999 as substantially equivalent to K971184 (Snap Laboratories, LLC, 1997) after a 187-day review. Its family tree reaches back 2 generations to 1995. 4 later devices descend from it.
- Decided
- May 26, 1999
- Review
- 187 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K944524 (1995). 4 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK944524 Snap Testing DeviceSnap Laboratories, LLC · 1995
- 1 generation backK971184 Oxi-SnapSnap Laboratories, LLC · 1997
- This deviceK984169 Digi-SnapSnap Laboratories, LLC · 1999
- Descendant · cites it directly · 3 of its ownK992322 Snap Model 5Snap Laboratories, LLC · 2000
- Descendant · 2 generations on · 2 of its ownK080321 Snap Model 7 Snoring and Apnea Recording and Analysis SystemSnap Laboratories, LLC · 2008
- Descendant · 3 generations on · 1 of its ownK110064 Snap Model 8 Snoring and Apnea Recording and Analysis SystemSnap Diagnostics, LLC · 2011
- Descendant · 4 generations on · 0 of its ownK240100 SAM Model 9-10000Snap Diagnostics, LLC · 2024
Most influential descendants
Showing 4 of 4 · See all- K992322Snap Model 5Snap Laboratories, LLC · 2000 · cites it directly3descendants
- K080321Snap Model 7 Snoring and Apnea Recording and Analysis SystemSnap Laboratories, LLC · 2008 · 2 generations on2descendants
- K110064Snap Model 8 Snoring and Apnea Recording and Analysis SystemSnap Diagnostics, LLC · 2011 · 3 generations on1descendant
- K240100SAM Model 9-10000Snap Diagnostics, LLC · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K944524 | Snap Testing Device | Snap Laboratories, LLC | 1995 | — |
| −1 | K971184 | Oxi-Snap | Snap Laboratories, LLC | 1997 | — |
| 0 (this device) | K984169 | Digi-Snap | Snap Laboratories, LLC | 1999 | — |
| +1 | K992322 | Snap Model 5 | Snap Laboratories, LLC | 2000 | — |
| +2 | K080321 | Snap Model 7 Snoring and Apnea Recording and Analysis System | Snap Laboratories, LLC | 2008 | — |
| +3 | K110064 | Snap Model 8 Snoring and Apnea Recording and Analysis System | Snap Diagnostics, LLC | 2011 | — |
| +4 | K240100 | SAM Model 9-10000 | Snap Diagnostics, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 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 |
|---|---|---|---|
| * | K971184 | Oxi-SnapSummary page 1…oring and Apnea Recording and Analysis Device 2. Equivalent legally marketed devices This product is similar in design and function to the "Oxi-Snap ™" Testing Device," K971184, and incorporates a different Pulse Oximeter, Nonin Model 8500 (OEM II Module or the Xpod Module), K893221. 3. The intended use… | 1997 |
| † | K893221 | Model 8500 Hand Held Pulse Oximeter | 1990 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K992322 | Snap Model 5 | 2000 | 3 |
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 4 years and passes through 1 company; a new generation was cleared every 1.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K992322 (Snap Laboratories, LLC, 2000) has gone furthest, with 3 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.
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 intended use of the "Digi-Snap ™" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring. The Digi-Snap testing system is only intended for short term monitoring such as to record the oximetry and snoring sounds continuously during the night. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements or EEG…
Read the full statement (168 words)
The intended use of the "Digi-Snap ™" device is to screen patients for apnea and snoring and to provide quantitative and qualitative analysis of apnea and snoring.
The Digi-Snap testing system is only intended for short term monitoring such as to record the oximetry and snoring sounds continuously during the night. The system is not intended as a substitute for full polysomnography when additional parameters such as sleep stages, limb movements or EEG activity are required.
The target population is patients who are suspected of apnea and/or complain about snoring. The majority of the screenings are going to take place at the patient's home, although some may take place in a sleep laboratory. Both pediatric and adult patients may be tested.
CAUTION: US Federal law restricts this device to sale by or on the order of a physician, 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 "Digi-Snap ™" device.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984169 · printed Nov 4, 2026
Cite this page
510(k) Report. “K984169: Digi-Snap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K984169
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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