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FDA 510(k)

CARA System

K-Number: K252500 · 2026-02-20

ApplicantCara Medical, Ltd.
Decision Date2026-02-20
Product CodeOWB
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

CARA System is a medical device manufactured by Cara Medical, Ltd.. It received FDA 510(k) clearance on 2026-02-20 under approval number K252500. The device is classified under product code OWB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CARA System?

CARA System is a medical device that received FDA 510(k) clearance on 2026-02-20. It is manufactured by Cara Medical, Ltd.. The 510(k) number is K252500.

When was CARA System approved by the FDA?

CARA System received FDA 510(k) clearance on 2026-02-20, under approval number K252500.

What company makes CARA System?

CARA System is manufactured by Cara Medical, Ltd..

What is the FDA product code for CARA System?

The FDA product code for CARA System is OWB.

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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.

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