CDI OneView Monitoring System— 510(k) K234065
Substantially EquivalentTerumo Cardiovascular Systems Corporation
FDA 510(k) clearance K234065 for CDI OneView Monitoring System, Substantially Equivalent on 2024-04-25. Applicant: Terumo Cardiovascular Systems Corporation. Device class: 2.
Clearance details
- Applicant
- Terumo Cardiovascular Systems Corporation
- Product code
- Code DRY
- Device class
- Class 2
- Regulation
- 21 CFR 870.4330
- Advisory panel
- Cardiovascular
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Ann Arbor, MI, US
Recent devices under product code DRY
view allMore clearances from Terumo Cardiovascular Systems Corporation
view all- K221895 — Terumo Advanced Perfusion System 1
- K200091 — Capiox iCP Centrifugal Pump
- K180950 — Terumo Capiox NX19 Oxygenator with Reservoir (east Orientation), Terumo Capiox NX19 Oxygenator with Reservoir (west Orientation), Terumo Capiox NX19 Oxygenator (east Orientation), Terumo Capiox NX19 Oxygenator (west Orientation)
- K172071 — Terumo Capiox NX19 Oxygenator with Reservoir (east orientation ), Terumo Capiox NX19 Oxygenator with Reservoir (west orientation ), Terumo Capiox NX19 Oxygenator (east orientation ), Terumo Capiox NX19 Oxygenator (west orientation)
- K172220 — Advanced Perfusion System 1
Adverse events under product code DRY
product code DRY- Death
- 5
- Total
- 5
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 →
Recalls naming K234065
K-number listed on FDA's recall record- Z-2018-2025 — CDI OneView System BPM Probe: Cat. No. CDI753 - CDI OneView BPM Probe, Cat. No. CDI753TK - CDI OneView BPM Probe Trial Kit
- Z-1492-2025 — Terumo CDI OneView Monitoring System Hematocrit / Oxygen Saturation Probe, Catalog Number REF CD1754
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K234065.
Data sourced from openFDA. This site is unofficial and independent of the FDA.