INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02— 510(k) K020386
Substantially EquivalentInvacare Corp.
FDA 510(k) clearance K020386 for INVACARE PLATINUM, MODELS IRC 5LX AND IRC 5LX02, Substantially Equivalent on 2002-07-02. Applicant: Invacare Corp.. Device class: 2.
Clearance details
- Applicant
- Invacare Corp.
- Product code
- Code CAW
- Device class
- Class 2
- Regulation
- 21 CFR 868.5440
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Elyria, OH, US
Recent devices under product code CAW
view allMore clearances from Invacare Corp.
view allAdverse events under product code CAW
product code CAW- Death
- 204
- Injury
- 573
- Malfunction
- 1,400
- Other
- 6
- Total
- 2,183
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 K020386
K-number listed on FDA's recall record- Z-0872-2015 — Component- Dianz Capacitor used in PerfectO2 Oxygen Concentrator, packaged one unit per box.
- Z-0577-2015 — Invacare Perfecto 2 V Oxygen Concentrator The finished device is packaged as a single unit. The service part contains a single pair of sieve beds; one pair of sieve beds is used in a single finished device. Intended to provide supplemental oxygen to patients with respiratory disorders, by separating nitrogen from room air, by way of a molecular sieve.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K020386.
Data sourced from openFDA. This site is unofficial and independent of the FDA.