510(k) · Cleared
ClearedN9+
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nonagon, Ltd. · DQD Stethoscope, Electronic
Cleared on Apr 14, 2023 as substantially equivalent to K202483 (Myhomedoc, Ltd., 2021) and 2 other predicates after a 119-day review. Its family tree reaches back 8 generations to 1996.
- Decided
- Apr 14, 2023
- Review
- 119 days
- Class
- Class II
- Product code
- DQD
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 8 generations to K952882 (1996). 43 ancestors in all, the oldest K771653 (1977). No later device cites it as a predicate yet.
- Root · 8 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 7 generations backK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
- 6 generations backK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
- 5 generations backK034046 RNK Telephonic Stethoscope, Model TR-1Rnk Products · 2004
- 4 generations backK072026 RNK Electronic StethoscopeRnk Products, Inc. · 2007
- 3 generations backK102893 PCP/PC StethoscopeRnk Products, Inc. · 2011
- 2 generations backK160401 Tyto StethoscopeTyto Care, Ltd. · 2016
- 1 generation backK181612 Tyto Stethoscope (OTC)Tyto Care, Ltd. · 2018
- This deviceK223785 N9+Nonagon, Ltd. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| −7 | K964554 | Personal Telemedicine Module | American Telecare, Inc. | 1996 | — |
| −6 | K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | American Telecare, Inc. | 1997 | — |
| −5 | K034046 | RNK Telephonic Stethoscope, Model TR-1 | Rnk Products | 2004 | — |
| −4 | K072026 | RNK Electronic Stethoscope | Rnk Products, Inc. | 2007 | — |
| −3 | K102893 | PCP/PC Stethoscope | Rnk Products, Inc. | 2011 | — |
| −2 | K160401 | Tyto Stethoscope | Tyto Care, Ltd. | 2016 | — |
| −1 | K181612 | Tyto Stethoscope (OTC) | Tyto Care, Ltd. | 2018 | — |
| 0 (this device) | K223785 | N9+ | Nonagon, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1977 | 1 | 0 |
| 1987 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 0 |
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2000 | 3 | 0 |
| 2001 | 2 | 0 |
| 2003 | 1 | 0 |
| 2004 | 3 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K202483 | MyHomeDocSummary page 4…and Otoscope Regulatory Class: Class II Product Code: DQD, FLL, DQA, ERA III. PREDICATE DEVICE Primary predicate: MyHomeDoc device (K202483), Regulation Number: 870.1875 Classification Product Code: DQD Subsequent Product Codes: DQA, ERA, FLL Secondary… | 2021 |
| * | K190242 | Tyto ThermometerSummary page 4…0.1875 Classification Product Code: DQD Subsequent Product Codes: DQA, ERA, FLL Secondary predicates: Tyto Care Ltd. Tyto Thermometer (OTC) cleared under K190242 Regulation Number: 21 CFR 880.2910 Product Code: FLL TytoCare Ltd. Tyto Stethoscope (OTC) cleared under K181612… | 2019 |
| * | K181612 | Tyto Stethoscope (OTC)Summary page 4…d. Tyto Thermometer (OTC) cleared under K190242 Regulation Number: 21 CFR 880.2910 Product Code: FLL TytoCare Ltd. Tyto Stethoscope (OTC) cleared under K181612 Regulation Number: 21 CFR 870.1875 Product Code: DQD K2… | 2018 |
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 27 years and passes through 5 companies; a new generation was cleared every 3.6 years on median.
- 2 of the 43 ancestors have a recall of any class.
How does its category compare?
All DQD devicesDQD Stethoscope, Electronic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 N9+ (OTC) device, combined with a smartphone application, is a multiple-sensor device that is intended to measure, record, and transmit the recorded data of auscultation sound of human body, human body temperature, oxygen saturation (SpO2) and pulse rate, and images of an examined body part.
N9+ (OTC) device is intended for use by adult lay users in a non-clinical environment. Nonagon application enables counseling with the physician and transmission of the information over an IP network.
The oxygen saturation (SpO2) sensor of the device is for Rx only.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223785 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223785: N9+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223785
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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