Cleared Traditional

K102138 - ULTRASONIC TABLETOP DOPPLER

Also marketed or referenced as:
ULTRASONIC TABLETOP DOPPLER

K102138 is an FDA 510(k) clearance for ULTRASONIC TABLETOP DOPPLER, manufactured by Edan Instruments, Inc.. The device is a Class 2 Radiology device with product code MAA cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K102138 · Edan Instruments, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2010
Decision
90d
Days
Class 2
Risk

K102138 is an FDA 510(k) clearance for the ULTRASONIC TABLETOP DOPPLER. Classified as Monitor, Fetal Doppler Ultrasound (product code MAA), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on October 28, 2010 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 884.2660 - the FDA radiology and imaging software oversight 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 Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Edan Instruments, Inc. devices

FDA 510(k) Submission Details - K102138

510(k) Number K102138 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2010
Decision Date October 28, 2010
Days to Decision 90 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 107d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MAA Device Classification - Class 2, Special Controls

Product Code MAA Monitor, Fetal Doppler Ultrasound
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 Radiology devices follow this clearance model.

Regulatory Peers - MAA Monitor, Fetal Doppler Ultrasound

All 7
Devices cleared under the same product code (MAA) and FDA review panel - the closest regulatory comparables to K102138.
LIFEDOP MODEL, L350R
K090499 · Summit Doppler Systems, Inc. · Mar 2009
GE SONOCHROME
K915138 · GE Medical Systems · Oct 1992
FETAL DOPPLER
K905536 · Toshiba America Medical Systems, In.C · Apr 1992
L582 TRANSDUCER
K904600 · Acuson Corp. · Jun 1991
L328 TRANSDUCER
K905456 · Acuson Corp. · May 1991
S5192R TRANSDUCER
K904951 · Acuson Corp. · Apr 1991