Cleared Traditional

K142716 - VCARE

K142716 is an FDA 510(k) clearance for VCARE, manufactured by Conmed Corporation. The device is a Class 2 Obstetrics & Gynecology device with product code LKF cleared through the Traditional 510(k) pathway after a 140-day FDA review.

K142716 · Conmed Corporation · Obstetrics & Gynecology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2015
Decision
140d
Days
Class 2
Risk

K142716 is an FDA 510(k) clearance for the VCARE. Classified as Cannula, Manipulator/injector, Uterine (product code LKF), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on February 10, 2015 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Obstetrics & Gynecology FDA review panel, regulated under 21 CFR 884.4530 - 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.

FDA 510(k) Submission Details - K142716

510(k) Number K142716 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2014
Decision Date February 10, 2015
Days to Decision 140 days
Submission Type Traditional
Review Panel Obstetrics & Gynecology (OB)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
21d faster than avg
Panel avg: 161d · This submission: 140d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LKF Device Classification - Class 2, Special Controls

Product Code LKF Cannula, Manipulator/injector, Uterine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 884.4530
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 - LKF Cannula, Manipulator/injector, Uterine

All 86
Devices cleared under the same product code (LKF) and FDA review panel - the closest regulatory comparables to K142716.
ManipulatOR PRO, ManipulatOR
K150519 · Gynetech Pty. , Ltd. · Aug 2015
SonoFlow Sonohysterography and Sonohysterosalpingography Device
K142545 · Crossbay Medical, Inc. · Mar 2015
Air Bubble Based Infuser (ABBI)
K143415 · CooperSurgical, Inc. · Feb 2015
MANIPULATOR
K142164 · Gynetech Pty. , Ltd. · Dec 2014
ALLY UPS
K141523 · CooperSurgical, Inc. · Nov 2014
CLEARVIEW TOTAL
K131781 · Clinical Innovations, LLC · May 2014
K142716 · VCARE
Download PDF FDA Summary Conmed Corporation