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FDA 510(k)

PanopticAI Vital Signs (1.6.1-22)

K-Number: K260066 · 2026-05-21

ApplicantPanopticAI Technologies Limited
Decision Date2026-05-21
Product CodeQME
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PanopticAI Vital Signs (1.6.1-22) is the device name listed in this FDA 510(k) record. The listed applicant is PanopticAI Technologies Limited. It received FDA 510(k) clearance on 2026-05-21 under 510(k) number K260066. The device is classified under product code QME. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PanopticAI Vital Signs (1.6.1-22)?

PanopticAI Vital Signs (1.6.1-22) is a medical device that received FDA 510(k) clearance on 2026-05-21. The listed applicant is PanopticAI Technologies Limited. The 510(k) number is K260066.

When did PanopticAI Vital Signs (1.6.1-22) receive FDA 510(k) clearance?

PanopticAI Vital Signs (1.6.1-22) received FDA 510(k) clearance on 2026-05-21, under 510(k) number K260066.

Who is the listed applicant for PanopticAI Vital Signs (1.6.1-22)?

The FDA 510(k) record lists PanopticAI Technologies Limited as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PanopticAI Vital Signs (1.6.1-22)?

The FDA product code for PanopticAI Vital Signs (1.6.1-22) is QME.

Other records listing PanopticAI Technologies Limited as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K240890PanopticAI Vital Signs

Related Devices (Code: QME)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K254169SmartSpectra Vital Signs Monitor 1.0Presage Security, Inc. d/b/a Presage Technologies, Inc.K253650Anura Mobile Core SDK (M1)Nuralogix CorporationK251200Vital SignsOxehealth LimitedK243687Vital SignsOxehealth LimitedK250078Informed Vital Core Application (IVC App) (v2.0.0.2.0.0)Mindset Medical, Inc.K240890PanopticAI Vital SignsPanopticAI technologies Limited

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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