Not Cleared Direct

DEN160020 - CipherOx CRI Tablet (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN160020 · Flashback Technologies, Inc. · Cardiovascular device
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Dec 2016
Decision
211d
Days
Class 2
Risk

DEN160020 is an FDA 510(k) submission (not cleared) for the CipherOx CRI Tablet. Classified as Adjunctive Cardiovascular Status Indicator (product code PPW), Class II - Special Controls.

Submitted by Flashback Technologies, Inc. (Boulder, US). The FDA issued a Not Cleared (DENG) decision on December 21, 2016 after a review of 211 days.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2200 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Cardiovascular review framework.

View all Flashback Technologies, Inc. devices

Submission Details

510(k) Number DEN160020 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 24, 2016
Decision Date December 21, 2016
Days to Decision 211 days
Submission Type Direct
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d slower than avg
Panel avg: 125d · This submission: 211d
Pathway characteristics

Device Classification

Product Code PPW Adjunctive Cardiovascular Status Indicator
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2200
Definition The Adjunctive Cardiovascular Status Indicator Is A Prescription Device Based On Sensor Technology For The Measurement Of A Physical Parameter(s). This Device Is Intended For Adjunctive Use With Other Physical Vital Sign Parameters And Patient Information And Is Not Intended To Independently Direct Therapy.
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 Cardiovascular devices follow this clearance model.

Regulatory Peers - PPW Adjunctive Cardiovascular Status Indicator

All 7
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K213255 · Flashback Technologies, Inc. · Jun 2022