CARA System— 510(k) K252500

Name: FDA 510(k) clearance K252500
Creator: U.S. Food and Drug Administration
Published: 2026-02-20

Substantially Equivalent

Cara Medical, Ltd.

FDA 510(k) clearance K252500 for CARA System, Substantially Equivalent on 2026-02-20. Applicant: Cara Medical, Ltd.. Device class: 2.

Clearance details

Applicant: Cara Medical, Ltd.
Product code: Code OWB
Device class: Class 2
Regulation: 21 CFR 892.1650
Advisory panel: Radiology
Date received: 2025-08-08
Decision date: 2026-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rd. Town, VG

Download summary PDF View on FDA.gov ↗

Recent devices under product code OWB

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K253726 — uAngio AVIVA CX2026-08-21
K261413 — EXTRON 3; EXTRON 62026-08-19
K254205 — Zenition 302026-08-07
K260607 — Shield System (Siemens 30x40)2026-07-31
K253670 — SmartCT (R3.0 (L10))2026-07-10

Adverse events under product code OWB

product code OWB

Death: 49
Injury: 340
Malfunction: 36,973
Total: 37,362

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Data sourced from openFDA. This site is unofficial and independent of the FDA.