Cleared Special

K200107 - epoc Blood Analysis System

K200107 is an FDA 510(k) clearance for epoc Blood Analysis System, manufactured by Epocal, Inc.. The device is a Class 2 Chemistry device with product code CHL cleared through the Special 510(k) pathway after a 140-day FDA review.

K200107 · Epocal, Inc. · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2020
Decision
140d
Days
Class 2
Risk

K200107 is an FDA 510(k) clearance for the epoc Blood Analysis System. Classified as Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph (product code CHL), Class II - Special Controls.

Submitted by Epocal, Inc. (Ottawa, CA). The FDA issued a Cleared decision on June 5, 2020 after a review of 140 days - within the typical 510(k) review window.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.1120 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K200107

510(k) Number K200107 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 17, 2020
Decision Date June 05, 2020
Days to Decision 140 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
51d slower than avg
Panel avg: 89d · This submission: 140d
Pathway characteristics
Modification to existing cleared device.

CHL Device Classification - Class 2, Special Controls

Product Code CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 862.1120
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 Chemistry devices follow this clearance model.

Regulatory Peers - CHL Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

All 186
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K200107 · epoc Blood Analysis System
Download PDF FDA Summary Epocal, Inc.