Tyto Stethoscope (OTC)
FDA 510(k) K181612 · Tyto Care , Ltd.
510(k) numberK181612
Submission
- Device name
- Tyto Stethoscope (OTC)
- Applicant
- Tyto Care , Ltd.
Netanya, IL - Received
- June 19, 2018
- Decision date
- December 17, 2018
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DQD – Stethoscope, Electronic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.1875
- Specialty
- Cardiovascular
Other 510(k)s with product code DQD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K261494 | Smart Wireless Stethoscope (STEMO310);Smart Wireless Stethoscope (STEMO710);Smart…DQD · Traditional | Shanghai Hulu Devices Co., Ltd. | 07/31/2026SE |
| K261694 | CORE 300 Digital StethoscopeDQD · Traditional | Eko Health, Inc. | 07/23/2026SE |
| K252915 | AiSteth®DQD · Traditional | Ai Health Highway India Pvt., Ltd. | 05/22/2026SE |
| K252089 | Tyto Stethoscope (G3)DQD · Traditional | Tyto Care , Ltd. | 03/12/2026SE |
| K252076 | Kneevoice Cartilage Evaluation System (750-3600-001)DQD · Traditional | Kneevoice, Inc. | 02/06/2026SE |
| K252284 | eMurmur Heart AIDQD · Traditional | Csd Labs | 12/19/2025SE |
| K252595 | Stethophone ProDQD · Special | Sparrow Acoustics, Inc. | 09/12/2025SE |
| K251494 | Eko Foundation Analysis Software with Transformers (EFAST)DQD · Traditional | Eko Health, Inc. | 08/12/2025SE |
| K242971 | AccurSound Electronic Stethoscope (AS101)DQD · Traditional | Heroic Faith International , Ltd. | 11/25/2024SE |
| K240901 | StethophoneDQD · Traditional | Sparrow Acoustics, Inc. | 09/19/2024SE |
More from Sparrow Acoustics, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K252844 | Tyto Insights for Wheeze Detection (with PCCP)PHZ · Traditional | 06/02/2026SE |
| K252089 | Tyto Stethoscope (G3)DQD · Traditional | 03/12/2026SE |
| K243567 | Tyto Insights for Rhonchi DetectionPHZ · Traditional | 04/07/2025SE |
| K240555 | Tyto Insights for Crackles DetectionPHZ · Traditional | 07/02/2024SE |
| K232237 | Tyto Insights for Wheeze DetectionPHZ · Traditional | 12/13/2023SE |
| K221614 | TytoCare Lung Sounds AnalyzerPHZ · Traditional | 02/24/2023SE |
| K190242 | Tyto ThermometerFLL · Traditional | 03/27/2019SE |
| K160401 | Tyto StethoscopeDQD · Traditional | 10/19/2016SE |
Questions and answers
When was Tyto Stethoscope (OTC) cleared by the FDA?
Tyto Stethoscope (OTC) (K181612) received a 510(k) decision of Substantially Equivalent on December 17, 2018, 181 days after the submission was received.
What is the product code of K181612?
The FDA product code is DQD – Stethoscope, Electronic, a Class II (moderate risk) device regulated under 21 CFR 870.1875.