Cleared Traditional

K110124 - FETAL DOPPLER JPD-100S

K110124 is an FDA 510(k) clearance for FETAL DOPPLER JPD-100S, manufactured by Shenzhen Jumper Medical Equipment Co., Ltd.. The device is a Class 2 Radiology device with product code KNG cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K110124 · Shenzhen Jumper Medical Equipment Co., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 2011
Decision
17d
Days
Class 2
Risk

K110124 is an FDA 510(k) clearance for the FETAL DOPPLER JPD-100S. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Shenzhen Jumper Medical Equipment Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on February 4, 2011 after a review of 17 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Shenzhen Jumper Medical Equipment Co., Ltd. devices

FDA 510(k) Submission Details - K110124

510(k) Number K110124 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 18, 2011
Decision Date February 04, 2011
Days to Decision 17 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
90d faster than avg
Panel avg: 107d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

KNG Device Classification - Class 2, Special Controls

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 Radiology devices follow this clearance model.

Regulatory Consultant

Underwriters Laboratories, Inc.
MARC M MOUSER

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 42
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K110124.
FETAL DOPPLER
K112911 · Beijing Choice Electronic Technololgy Co., Ltd. · Oct 2011
PD-100 SERIES ULTRASONIC POCKET DOPPLER
K111934 · Advanced Instrumentations, Inc. · Sep 2011
F10
K110630 · Mediana Co., Ltd. · Jun 2011
DOPPLER FETAL HEART RATE DETECTOR, MODEL FM-200
K100626 · Shenzhen Biocare Electronics Co., Ltd. · May 2010
DOPPLER FETAL HEARTBEAT RATE DETECTOR
K090510 · Shenzhen Bestman Instrument Co., Ltd. · Apr 2010
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
K092997 · Edan Instruments, Inc. · Nov 2009