Cleared Traditional

K092116 - EASYCELL CELL LOCATOR

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

K092116 · Medica Corp. · Hematology device
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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.

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Submission Details

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
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.

Device Classification

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 7
Devices cleared under the same product code (JOY) and FDA review panel - the closest regulatory comparables to K092116.
CellaVision DC-1, CellaVision DC-1 PPA
K200595 · CellaVision AB · Oct 2020
X100 with Full Field Peripheral Blood Smear (PBS) Application
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Sysmex UD-10, Fully Automated Urine Particle Digital Imaging Device
K182062 · Sysmex America, Inc. · Oct 2018
SCANNING SYS., AUTO. COMP., ACS1000
K772140 · Honeywell, Inc. · Dec 1977