C-beam— 510(k) K252735
Substantially EquivalentPulmera, Inc.
FDA 510(k) clearance K252735 for C-beam, Substantially Equivalent on 2026-05-22. Applicant: Pulmera, Inc.. Device class: 2.
Summary
Pulmera's C-beam is filed under OWB, interventional fluoroscopic x-ray systems. The record doesn't describe it beyond its name and that code name.
Class II, 21 CFR 892.1650. Radiology is both the classification panel and the review panel. It came in as a Traditional 510(k).
Pulmera filed from Palo Alto, California. Review took 267 calendar days (August 28, 2025 to May 22, 2026).
Clearance details
- Applicant
- Pulmera, Inc.
- 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
- Palo Alto, CA, US
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.