Cleared Traditional

PanopticAI Vital Signs (1.6.1-22) (K260066) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K260066 · PanopticAI technologies Limited · Cardiovascular device
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May 2026
Decision
132d
Days
Class 2
Risk

K260066 is an FDA 510(k) clearance for the PanopticAI Vital Signs (1.6.1-22). Classified as Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate (product code QME), Class II - Special Controls.

Submitted by PanopticAI technologies Limited (Hong Kong, HK). The FDA issued a Cleared decision on May 21, 2026 after a review of 132 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2785 - the FDA cardiovascular device oversight 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 Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all PanopticAI technologies Limited devices

Submission Details

510(k) Number K260066 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 09, 2026
Decision Date May 21, 2026
Days to Decision 132 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
7d slower than avg
Panel avg: 125d · This submission: 132d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QME Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2785
Definition The Device Uses Software Algorithms To Analyze Video Signal And Estimate Pulse Rate, Heart Rate, Respiratory Rate And/or Breathing Rates. This Device 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 Consultant

Vee Care (Asia) Limited
Evie Chen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - QME Software For Optical Camera-based Measurement Of Pulse Rate, Heart Rate, Breathing Rate, And/or Respiratory Rate

All 10
Devices cleared under the same product code (QME) and FDA review panel - the closest regulatory comparables to K260066.
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PanopticAI Vital Signs
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Informed Vital Core Application (IVC App)
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FibriCheck
K232804 · Qompium NV · Jun 2024