SD5 & SD6 Ultrasonic Tabletop Doppler
510(k) K153475
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK153475 | Date29 Jan 2016 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA Product Code
- KNG
- Device Class
- Class II
- Regulation
- 21 CFR Part 884.2660
- Advisory Committee
- Obstetrics/Gynecology
- FDA Decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 1 Oct 2026
The SD5 & SD6 Ultrasonic Tabletop Doppler is a Monitor, Ultrasonic, Fetal device designed for obstetric and gynecological use. It utilizes ultrasonic Doppler technology to detect and amplify fetal heart rate signals, enabling real-time audio monitoring of fetal cardiac activity. This handheld and tabletop system is intended for non-invasive prenatal assessment, providing clinicians with critical information during obstetric evaluations.
The device is supplied as reusable and non-sterile, intended for clinical settings such as obstetrics and gynecology offices or delivery rooms. It features a tabletop base with a remote control probe and rolling stand for ease of use. The SD5 & SD6 complies with FDA Class 2 regulations and has received FDA 510K clearance (K153475). Storage requires protection from physical damage and extreme temperatures, with no specified sterility requirements.
SD5 & SD6 Ultrasonic Tabletop Doppler
Other devices from Edan Instruments, Inc.
Questions
AI-generated answers, 1 Oct 2026
What is the SD5 & SD6 Ultrasonic Tabletop Doppler used for?
The SD5 & SD6 Ultrasonic Tabletop Doppler is designed specifically for obstetric and gynecological use. It employs ultrasonic Doppler technology to detect and amplify fetal heart rate signals, enabling non-invasive, real-time audio monitoring of fetal cardiac activity during prenatal assessments or deliveries. This helps clinicians assess fetal well-being without invasive procedures.
How is the SD5 & SD6 Ultrasonic Tabletop Doppler supplied and intended for use?
The device is supplied as a reusable, non-sterile system intended exclusively for clinical settings such as obstetrics offices or delivery rooms. It includes a tabletop base, a remote control probe, and a rolling stand for portability and ease of use. Since it is non-sterile, it is not intended for direct patient contact without proper cleaning and disinfection between uses.
Is sterility required for the SD5 & SD6 Ultrasonic Tabletop Doppler?
No, sterility is not required for the SD5 & SD6 Ultrasonic Tabletop Doppler. The device is explicitly labeled as non-sterile and is designed for reusable clinical use. Proper cleaning and disinfection protocols must be followed between patients to maintain hygiene and prevent cross-contamination.
What storage conditions are recommended for the SD5 & SD6 Ultrasonic Tabletop Doppler?
The device should be stored in a protected environment to avoid physical damage and exposure to extreme temperatures. While specific storage guidelines are not detailed, standard clinical equipment practices—such as keeping it in a dry, stable location away from direct sunlight or moisture—are recommended to preserve functionality and longevity.
Does the SD5 & SD6 Ultrasonic Tabletop Doppler come in different models or sizes?
The SD5 & SD6 are distinct models within the same product line, differentiated by their design and features (e.g., SD5 and SD6 may vary slightly in functionality or probe specifications). However, the provided data does not specify additional size variations beyond the base and probe configuration. For precise model differences, refer to the manufacturer’s technical documentation or contact EDAN Instruments, Inc.