510(k) · Cleared
ClearedSnor-Scope Plus or Snor-Scope + Electronic Stethoscope System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Noble Anesthesia-Air, Inc. · DQD Stethoscope, Electronic
Cleared on Mar 6, 2009 as substantially equivalent to K034046 (Rnk Products, 2004) and 3 other predicates after a 185-day review. Its family tree reaches back 5 generations to 1977.
- Decided
- Mar 6, 2009
- Review
- 185 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 5 generations to K771653 (1977). 15 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK771653 Electronic Stethoscope3M Company · 1977
- 4 generations backK961857 Labtron Electromax Electronic Stethoscope Model NO. 04-1060Graham-Field, Inc. · 1996
- 3 generations backK991367 Meditron Stethoscope SystemMeditron AS · 1999
- 2 generations backK031446 Jabes Electronic StethoscopeGs Technology Co., Ltd. · 2003
- 1 generation backK062481 Sereno Electronic StethoscopePishon High Tech Co., Ltd. · 2006
- This deviceK082528 Snor-Scope Plus or Snor-Scope + Electronic Stethoscope SystemNoble Anesthesia-Air, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| −4 | K961857 | Labtron Electromax Electronic Stethoscope Model NO. 04-1060 | Graham-Field, Inc. | 1996 | — |
| −3 | K991367 | Meditron Stethoscope System | Meditron AS | 1999 | — |
| −2 | K031446 | Jabes Electronic Stethoscope | Gs Technology Co., Ltd. | 2003 | — |
| −1 | K062481 | Sereno Electronic Stethoscope | Pishon High Tech Co., Ltd. | 2006 | — |
| 0 (this device) | K082528 | Snor-Scope Plus or Snor-Scope + Electronic Stethoscope System | Noble Anesthesia-Air, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 5 | 0 |
| 1997 | 2 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 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 DQD? 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 DQD device
- #1 K200776 Eko COREscore 25.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K034046 | RNK Telephonic Stethoscope, Model TR-1 Our reading of the summary gave K030446, FDA’s number for Repicci Locked Keel Tibial Bearing (Biomet, Inc.). Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “RNK Products Stethoscope”. | 2004 |
| * | K072026 | RNK Electronic StethoscopeSummary page 1…tethoscope, Class II (Two) (21 CFR 870.1875(b), Product Code DQD) Predicate Devices: RNK Products Stethoscope (K030446, K072026) Pishon High Tech Co. Stethoscope (K062481 ) Meditron AS Stet… | 2007 |
| * | K062481 | Sereno Electronic StethoscopeSummary page 1…(b), Product Code DQD) Predicate Devices: RNK Products Stethoscope (K030446, K072026) Pishon High Tech Co. Stethoscope (K062481 ) Meditron AS Stethoscope (K991367) Related Accessories: (Kit) Classification… | 2006 |
| * | K991367 | Meditron Stethoscope SystemSummary page 1…s Stethoscope (K030446, K072026) Pishon High Tech Co. Stethoscope (K062481 ) Meditron AS Stethoscope (K991367) Related Accessories: (Kit) Classification Description Class 21 CFR 868.5240… | 1999 |
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 32 years and passes through 6 companies; a new generation was cleared every 3.0 years on median.
- None of the 15 ancestors has a recall.
- 3 other devices also cite its predicate K034046.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · DQD
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQD
89in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQD
No recall names DQD since 2007.
Adverse event reports per year · DQD
1in 2024
MAUDE reports naming product code DQD, 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 | 2 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 6 | 161 | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 4 | 107 | 0 | 1 |
| 2012 | 2 | — | 0 | 0 |
| 2013 | 5 | 70 | 0 | 1 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 0 |
| 2016 | 3 | 250 | 0 | 0 |
| 2017 | 4 | 109 | 0 | 0 |
| 2018 | 4 | 131 | 0 | 0 |
| 2019 | 4 | 262 | 0 | 0 |
| 2020 | 6 | 104 | 0 | 0 |
| 2021 | 4 | 137 | 0 | 0 |
| 2022 | 8 | 203 | 0 | 0 |
| 2023 | 10 | 132 | 0 | 0 |
| 2024 | 4 | 153 | 0 | 1 |
| 2025 | 3 | 89 | 0 | 0 |
| 2026 | 6 | 236 | 0 | — |
What is it indicated for?
The Noble Anesthesia-Air Snor-Scope PlusTM Electronic Stethoscope is intended as a diagnostic aid in patient monitoring, diagnostics, and treatment under the same conditions that would otherwise require the use of an acoustic (non-electronic) stethoscope.
In addition, the Noble Anesthesia-Air Snor-Scope Plus Electronic Stethoscope is also intended for electronically amplifying sounds of evolving obstruction of the upper airway in patients without an endotracheal tube undergoing sedation or general anesthesia by an anesthesia care professional.
It is not intended to be used for diagnosis and treatment by unlicensed, untrained, or unqualified medical persons.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K082528 · printed Nov 6, 2026
Cite this page
510(k) Report. “K082528: Snor-Scope Plus or Snor-Scope + Electronic Stethoscope System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K082528
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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