510(k) · Cleared
ClearedNoga Automated Sleep Study Scoring and Data Management System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Widemed, Ltd. · MNR Ventilatory Effort Recorder
Cleared on May 5, 2007 as substantially equivalent to K022506 (Widemed, Ltd., 2003) and 2 other predicates after an 89-day review. Its family tree reaches back 4 generations to 1991. 2 later devices descend from it.
- Decided
- May 5, 2007
- Review
- 89 days
- Class
- Class II
- Product code
- MNR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K910870 (1991). 21 ancestors in all, the oldest K873535 (1987). 2 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK910870 Edentec Model 3711 Digital RecorderEdentec Corp. · 1991
- 3 generations backK963597 Silent Night ILocal Silence, Inc. · 1997
- 2 generations backK981034 Silent Night IISleep Solutions, Inc. · 1998
- 1 generation backK000253 Silent Night VSleep Solutions, Inc. · 2000
- This deviceK070326 Noga Automated Sleep Study Scoring and Data Management SystemWidemed, Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK111314 Morpheus OXWidemed, Ltd. · 2011
- Descendant · cites it directly · 0 of its ownK073269 HC1000P Sleep Diagnosis Software SystemHypnocore, Ltd. · 2008
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 |
|---|---|---|---|---|---|
| −4 | K910870 | Edentec Model 3711 Digital Recorder | Edentec Corp. | 1991 | — |
| −3 | K963597 | Silent Night I | Local Silence, Inc. | 1997 | — |
| −2 | K981034 | Silent Night II | Sleep Solutions, Inc. | 1998 | — |
| −1 | K000253 | Silent Night V | Sleep Solutions, Inc. | 2000 | — |
| 0 (this device) | K070326 | Noga Automated Sleep Study Scoring and Data Management System | Widemed, Ltd. | 2007 | — |
| +1 | K111314 | Morpheus OX | Widemed, Ltd. | 2011 | — |
| +1 | K073269 | HC1000P Sleep Diagnosis Software System | Hypnocore, Ltd. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1987 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 2 | 0 |
| 1994 | 2 | 0 |
| 1996 | 2 | 0 |
| 1997 | 3 | 0 |
| 1998 | 2 | 0 |
| 1999 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2011 | 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? (3)
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 |
|---|---|---|---|
| * | K022506 | Morpheus 1, Automated Sleep Study Scoring & Data Management SystemSummary page 1…8 Device Class: Class II 5.9 Regulation Number: 868.2875 5.10 Panel: Anesthesiology 5.11 Predicate Device: 1. The Morpheus TM 1 (WideMed, Ltd.), cleared under K022506. 2. The Silent Night V (Sleep Solutions, Inc.), cleared under K000253. 3, Gold standard PSG manual sco… | 2003 |
| * | K000253 | Silent Night VSummary page 1…11 Predicate Device: 1. The Morpheus TM 1 (WideMed, Ltd.), cleared under K022506. 2. The Silent Night V (Sleep Solutions, Inc.), cleared under K000253. 3, Gold standard PSG manual scoring (e.g., manual scoring of ALICE-5 PSG, cleared under K040595)… | 2000 |
| * | K040595 | ALICE 5Summary page 1…t V (Sleep Solutions, Inc.), cleared under K000253. 3, Gold standard PSG manual scoring (e.g., manual scoring of ALICE-5 PSG, cleared under K040595) 5-3 5.15 Substantial Equivalence: Intended Use With regard to its… | 2004 |
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 16 years and passes through 4 companies; a new generation was cleared every 5.4 years on median.
- 1 of the 21 ancestors has a recall of any class.
- Of its descendants, K111314 (Widemed, Ltd., 2011) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K022506.
How does its category compare?
All MNR devicesMNR Ventilatory Effort Recorder: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, 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 Noga Automated Sleep Study Scoring and Data Management System is a computer program (software) intended for use as an aid for the diagnosis of respiratory related sleep disorders.
The Noga System is intended to be used for analysis, display, redisplay (tettieve), summarize, reports generation and networking of physiological data received from a physiological activity monitoring device.
Physiological data includes: ECO, SpO2, EtCO 2 and Impedance respiration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070326 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070326: Noga Automated Sleep Study Scoring and Data Management System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070326
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