Cleared Traditional

SD1 Ultrasonic Pocket Doppler (K172780) - FDA 510(k) Clearance

Class II Obstetrics & Gynecology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K172780 · Edan Instruments, Inc. · Obstetrics & Gynecology device
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Jun 2018
Decision
265d
Days
Class 2
Risk

K172780 is an FDA 510(k) clearance for the SD1 Ultrasonic Pocket Doppler. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on June 6, 2018 after a review of 265 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.2660 - the FDA obstetrics and gynecology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Obstetrics & Gynecology review framework, consistent with the majority of Class II 510(k) submissions.

View all Edan Instruments, Inc. devices

Submission Details

510(k) Number K172780 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 2017
Decision Date June 06, 2018
Days to Decision 265 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
105d slower than avg
Panel avg: 160d · This submission: 265d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KNG Monitor, Ultrasonic, Fetal
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.2660
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Obstetrics & Gynecology devices follow this clearance model.

Regulatory Consultant

Edan Medical
Alice Yang

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - KNG Monitor, Ultrasonic, Fetal

All 19
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K172780.
Fetal Doppler, Model FD88
K182710 · Shenzzhen Luckcome Technology Inc., Ltd. · Mar 2019
Fetal Doppler
K182190 · Shenzhen AOJ Medical Technology Co., Ltd. · Dec 2018
Ultrasonic Doppler (Model YM-2T8)
K180419 · Shenzhen Imdk Medical Technology Co., Ltd. · Jul 2018
SD5 & SD6 Ultrasonic Tabletop Doppler
K153475 · Edan Instruments, Inc. · Jan 2016
ULTRASONIC POCKET DOPPLER
K140579 · Edan Instruments, Inc. · Feb 2015
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
K092997 · Edan Instruments, Inc. · Nov 2009