Cleared Traditional

K142207 - TransferMan 4m Micromanipulator

K142207 is an FDA 510(k) clearance for TransferMan 4m Micromanipulator, manufactured by Eppendorf AG. The device is a Class 2 Obstetrics & Gynecology device with product code MQJ cleared through the Traditional 510(k) pathway after a 165-day FDA review.

K142207 · Eppendorf AG · Obstetrics & Gynecology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
165d
Days
Class 2
Risk

K142207 is an FDA 510(k) clearance for the TransferMan 4m Micromanipulator. Classified as Micromanipulators And Microinjectors, Assisted Reproduction (product code MQJ), Class II - Special Controls.

Submitted by Eppendorf AG (Hamburg, DE). The FDA issued a Cleared decision on January 23, 2015 after a review of 165 days - an extended review cycle.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.6150 - 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 Eppendorf AG devices

FDA 510(k) Submission Details - K142207

510(k) Number K142207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 11, 2014
Decision Date January 23, 2015
Days to Decision 165 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
5d slower than avg
Panel avg: 160d · This submission: 165d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MQJ Device Classification - Class 2, Special Controls

Product Code MQJ Micromanipulators And Microinjectors, Assisted Reproduction
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.6150
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 - MQJ Micromanipulators And Microinjectors, Assisted Reproduction

All 21
Devices cleared under the same product code (MQJ) and FDA review panel - the closest regulatory comparables to K142207.
MICROMANIPULATOR SET
K120877 · Narishige Co., Ltd. · Jun 2012
IM-11 PNEUMATIC MICROINJECTOR
K113712 · Narishige Co., Ltd. · Mar 2012
MM-87 MOTOR-DRIVE MANIPULATOR
K011420 · Narishige Co., Ltd. · Jun 2001
MN-4 COARSE MANIPULATOR
K010298 · Narishige Co., Ltd. · Mar 2001
MO-202D THREE-AXIS HANGING JOYSTICK OIL HYDRAULIC MICROMANIPATOR
K003300 · Narishige Co., Ltd. · Nov 2000
IM-5A INJECTOR
K003302 · Narishige Co., Ltd. · Nov 2000