FDA 510(k)

EarliPoint System

K-Number: K243891 · 2025-03-26

Decision Date2025-03-26

Product CodeQPF

Advisory CommitteeNE

DecisionSubstantially Equivalent

Device Summary

EarliPoint System is the device name listed in this FDA 510(k) record. The listed applicant is Earlitec Diagnostics. It received FDA 510(k) clearance on 2025-03-26 under 510(k) number K243891. The device is classified under product code QPF. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the EarliPoint System?

EarliPoint System is a medical device that received FDA 510(k) clearance on 2025-03-26. The listed applicant is Earlitec Diagnostics. The 510(k) number is K243891.

When did EarliPoint System receive FDA 510(k) clearance?

EarliPoint System received FDA 510(k) clearance on 2025-03-26, under 510(k) number K243891.

Who is the listed applicant for EarliPoint System?

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

What is the FDA product code for EarliPoint System?

The FDA product code for EarliPoint System is QPF.

Other records listing Earlitec Diagnostics 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.

K253442EarliPoint Assessment K230337EarliPoint K213882EarliPoint System

Related Devices (Code: QPF)

K253442EarliPoint AssessmentEarlitec Diagnostics K243558Canvas DxCognoa, Inc.K230337EarliPointEarlitec Diagnostics, Inc.K213882EarliPoint SystemEarlitec Diagnostics, Inc.

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.