Affinity
K-Number: K253835 · 2026-07-31
Device Summary
Frequently Asked Questions
What is the Affinity?
Affinity is a medical device that received FDA 510(k) clearance on 2026-07-31. The listed applicant is Hermes Medical Solutions AB. The 510(k) number is K253835.
When did Affinity receive FDA 510(k) clearance?
Affinity received FDA 510(k) clearance on 2026-07-31, under 510(k) number K253835.
Who is the listed applicant for Affinity?
The FDA 510(k) record lists Hermes Medical Solutions AB as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for Affinity?
The FDA product code for Affinity is QIH.
Other records listing Hermes Medical Solutions AB 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.
Related Devices (Code: QIH)
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.
Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.