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FDA 510(k)

Deterioration Index Version 2

K-Number: K260008 · 2026-09-18

ApplicantEpic Systems Corporation
Decision Date2026-09-18
Product CodeQNL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Deterioration Index Version 2 is the device name listed in this FDA 510(k) record. The listed applicant is Epic Systems Corporation. It received FDA 510(k) clearance on 2026-09-18 under 510(k) number K260008. The device is classified under product code QNL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Deterioration Index Version 2?

Deterioration Index Version 2 is a medical device that received FDA 510(k) clearance on 2026-09-18. The listed applicant is Epic Systems Corporation. The 510(k) number is K260008.

When did Deterioration Index Version 2 receive FDA 510(k) clearance?

Deterioration Index Version 2 received FDA 510(k) clearance on 2026-09-18, under 510(k) number K260008.

Who is the listed applicant for Deterioration Index Version 2?

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

What is the FDA product code for Deterioration Index Version 2?

The FDA product code for Deterioration Index Version 2 is QNL.

Related Devices (Code: QNL)

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.

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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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