Cleared Traditional

K131457 - FETAL ULTRASONIC MONITOR AND ACCESSORIES (FDA 510(k) Clearance)

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

K131457 · Shenzhen Jumper Medical Equipment Co., Ltd. · Obstetrics & Gynecology device
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Jan 2014
Decision
249d
Days
Class 2
Risk

K131457 is an FDA 510(k) clearance for the FETAL ULTRASONIC MONITOR AND ACCESSORIES. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Shenzhen Jumper Medical Equipment Co., Ltd. (Shenzhen, Guangdon, CN). The FDA issued a Cleared decision on January 24, 2014 after a review of 249 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 Shenzhen Jumper Medical Equipment Co., Ltd. devices

Submission Details

510(k) Number K131457 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2013
Decision Date January 24, 2014
Days to Decision 249 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
89d slower than avg
Panel avg: 160d · This submission: 249d
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 Peers - KNG Monitor, Ultrasonic, Fetal

All 59
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K131457.
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