MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS— 510(k) K914488
Substantially EquivalentInvacare Corp.
FDA 510(k) clearance K914488 for MODELS: IRCRF5, IRCPF16 FLOWMETER ACCESSORY KITS, Substantially Equivalent on 1992-09-15. 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 K914488
K-number listed on FDA's recall record- Z-2364-2016 — lnvacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16. Packed one per carton. The lnvacare Precise Rx Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.
- Z-2365-2016 — Invacare Precise Rx Pediatric Flowmeter Model Number: IRCPF16 AW. Packed one per carton. The lnvacare Precise Rx" Pediatric Flowmeter adapts to lnvacare Concentrators for low-flow usage.The gauge has a scale printed on the front side and the back side. The front scale is the primary source for monitoring oxygen flow. The rear scale is an aide for monitoring oxygen flow.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K914488.
Data sourced from openFDA. This site is unofficial and independent of the FDA.