CARA System— 510(k) K252500
Substantially EquivalentCara Medical, Ltd.
FDA 510(k) clearance K252500 for CARA System, Substantially Equivalent on 2026-02-20. Applicant: Cara Medical, Ltd.. Device class: 2.
Summary
Cara Medical's CARA System is filed under product code OWB, interventional fluoroscopic x-ray system. The record doesn't describe the system beyond its name and that code name.
Class II, 21 CFR 892.1650. Radiology is both the classification panel and the review panel, and it came in as a Traditional 510(k).
The record lists the applicant location as Rd. Town, with country code VG. The decision came 196 calendar days after FDA received it (August 8, 2025 to February 20, 2026), and it was substantially equivalent.
Clearance details
- Applicant
- Cara Medical, Ltd.
- Product code
- Product code OWB
- Device class
- Class 2
- Regulation
- 21 CFR 892.1650
- Advisory panel
- Radiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Rd. Town, VG
Recent devices under product code OWB
view allAdverse events under product code OWB
product code OWB- Death
- 49
- Injury
- 340
- Malfunction
- 36,973
- Total
- 37,362
Source: openFDA MAUDE database, through . 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.