Cleared Traditional

K110630 - F10

K110630 is an FDA 510(k) clearance for F10, manufactured by Mediana Co., Ltd.. The device is a Class 2 Obstetrics & Gynecology device with product code KNG cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K110630 · Mediana Co., Ltd. · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
113d
Days
Class 2
Risk

K110630 is an FDA 510(k) clearance for the F10. Classified as Monitor, Ultrasonic, Fetal (product code KNG), Class II - Special Controls.

Submitted by Mediana Co., Ltd. (Wonju-City, Gangwon-Do, KR). The FDA issued a Cleared decision on June 24, 2011 after a review of 113 days - within the typical 510(k) review window.

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 Mediana Co., Ltd. devices

FDA 510(k) Submission Details - K110630

510(k) Number K110630 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 03, 2011
Decision Date June 24, 2011
Days to Decision 113 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
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
47d faster than avg
Panel avg: 160d · This submission: 113d
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 Obstetrics & Gynecology 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 36
Devices cleared under the same product code (KNG) and FDA review panel - the closest regulatory comparables to K110630.
TD-5000 & TD-6000 ULTRASONIC TABLETOP DOPPLER
K112529 · Advanced Instrumentations, Inc. · Oct 2011
FETAL DOPPLER
K112911 · Beijing Choice Electronic Technololgy Co., Ltd. · Oct 2011
PD-100 SERIES ULTRASONIC POCKET DOPPLER
K111934 · Advanced Instrumentations, Inc. · Sep 2011
FETAL DOPPLER JPD-100S
K110124 · Shenzhen Jumper Medical Equipment Co., Ltd. · Feb 2011
ULTRASONIC TABLETOP DOPPLER, MODELS SD5 AND SD6
K092997 · Edan Instruments, Inc. · Nov 2009
SONOTRAX ULTRASONIC FETAL AND VASCULAR POCKET DOPPLER, MODELS LITE, BASIC, PRO, II, II PRO AND VASCULAR
K080087 · Edan Instruments, Inc. · Mar 2008

FDA 510(k) Resources - Obstetrics & Gynecology

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.