Arc Adjustable Radial Cuff Compression Device— 510(k) K252772
Substantially EquivalentTz Medical, Inc.
FDA 510(k) clearance K252772 for Arc Adjustable Radial Cuff Compression Device, Substantially Equivalent on 2026-05-22. Applicant: Tz Medical, Inc.. Device class: 2.
Summary
Tz Medical's Arc Adjustable Radial Cuff Compression Device is filed under DXC, vascular clamps.
Class II, 21 CFR 870.4450. Cardiovascular is both the classification panel and the review panel, and the submission was a Traditional 510(k).
Tz Medical filed from Tualatin, Oregon. The decision came 262 calendar days after receipt (September 2, 2025 to May 22, 2026).
Clearance details
- Applicant
- Tz Medical, Inc.
- Product code
- Product code DXC
- Device class
- Class 2
- Regulation
- 21 CFR 870.4450
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Tualatin, OR, US
Recent devices under product code DXC
view all- K262086 — PreludeSYNC Radial Compression Device
- K260105 — Fogarty Spring Clips, Handleless Clamps, and Clamp Inserts
- K254060 — Life Saving Tourniquet
- K243627 — Laryngoscope Junctional-Arterial Restriction Clamp (L-ARC); Arterial Restriction Clamp (ARC)
- K253070 — Namic Radial Arm Band, 23 cm (DYNJRADBAND); Namic Radial Arm Band, 26 cm (DYNJRADBANDL)
More clearances from Tz Medical, Inc.
view allAdverse events under product code DXC
product code DXC- Death
- 14
- Injury
- 442
- Malfunction
- 2,209
- Other
- 1
- Total
- 2,666
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.