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FDA 510(k)

Aerloom

K-Number: K254217 · 2026-08-31

ApplicantEvolym, LLC
Decision Date2026-08-31
Product CodeJOW
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

Aerloom is the device name listed in this FDA 510(k) record. The listed applicant is Evolym, LLC. It received FDA 510(k) clearance on 2026-08-31 under 510(k) number K254217. The device is classified under product code JOW. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Aerloom?

Aerloom is a medical device that received FDA 510(k) clearance on 2026-08-31. The listed applicant is Evolym, LLC. The 510(k) number is K254217.

When did Aerloom receive FDA 510(k) clearance?

Aerloom received FDA 510(k) clearance on 2026-08-31, under 510(k) number K254217.

Who is the listed applicant for Aerloom?

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

What is the FDA product code for Aerloom?

The FDA product code for Aerloom is JOW.

Related Devices (Code: JOW)

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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