Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

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 the device name listed in this FDA 510(k) record. The listed applicant is Cara Medical, Ltd.. It received FDA 510(k) clearance on 2026-02-20 under 510(k) 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. The listed applicant is Cara Medical, Ltd.. The 510(k) number is K252500.

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

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

Who is the listed applicant for CARA System?

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

What is the FDA product code for CARA System?

The FDA product code for CARA System is OWB.

Related Devices (Code: OWB)

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.

K254205Zenition 30Philips Medical Systems Nederland B.V.K260607Shield System (Siemens 30x40)Radiaction , Ltd.K253670SmartCT (R3.0 (L10))Philips Medical Systems B.V.K252735C-beamPulmera, Inc.K252503Intelligent NRCanon, Inc.K254173ARTIS icono floor; ARTIS icono biplane; ARTIS icono ceiling; ARTIS phenoSiemens Medical Solutions USA, Inc.

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.

↑