Cleared Traditional

K092116 - EASYCELL CELL LOCATOR

K092116 is an FDA 510(k) clearance for EASYCELL CELL LOCATOR, manufactured by Medica Corp.. The device is a Class 2 Hematology device with product code JOY cleared through the Traditional 510(k) pathway after a 302-day FDA review.

K092116 · Medica Corp. · Hematology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2010
Decision
302d
Days
Class 2
Risk

K092116 is an FDA 510(k) clearance for the EASYCELL CELL LOCATOR. Classified as Device, Automated Cell-locating (product code JOY), Class II - Special Controls.

Submitted by Medica Corp. (Beverly, US). The FDA issued a Cleared decision on May 12, 2010 after a review of 302 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5260 - the FDA hematology 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K092116

510(k) Number K092116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 2009
Decision Date May 12, 2010
Days to Decision 302 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
189d slower than avg
Panel avg: 113d · This submission: 302d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOY Device Classification - Class 2, Special Controls

Product Code JOY Device, Automated Cell-locating
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5260
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 Hematology devices follow this clearance model.

Regulatory Peers - JOY Device, Automated Cell-locating

All 34
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K092116.
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K092868 · CellaVision AB · Nov 2009
CELLAVISION DM96 WITH THE BODY FLUID APPLICATION
K080595 · CellaVision AB · Dec 2008
SCANVIEW, MODEL SC-300
K071398 · Applied Spectral Imaging , Ltd. · Oct 2007
K092116 · EASYCELL CELL LOCATOR
Download PDF FDA Summary Medica Corp.