AVEA— 510(k) K013642
Substantially EquivalentBird Products Corp.
FDA 510(k) clearance K013642 for AVEA, Substantially Equivalent on 2002-05-22. Applicant: Bird Products Corp.. Device class: 2.
Clearance details
- Applicant
- Bird Products Corp.
- Product code
- Code CBK
- Device class
- Class 2
- Regulation
- 21 CFR 868.5895
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Palm Spring, CA, US
Recent devices under product code CBK
view allMore clearances from Bird Products Corp.
view allAdverse events under product code CBK
product code CBK- Death
- 736
- Injury
- 3,628
- Malfunction
- 98,786
- Other
- 4
- Total
- 103,154
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 K013642
K-number listed on FDA's recall record- Z-1888-2016 — AVEA Comprehensive ventilator, 17310-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Z-1889-2016 — AVEA Standard ventilator, 17311-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Z-1890-2016 — AVEA Standard with Compressor ventilator, 17312-xx (xx = 0 - 14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Z-1891-2016 — AVEA Comprehensive ventilator-refurbished, R17310-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Z-1892-2016 — AVEA Standard ventilator-refurbished, R17311-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Z-1893-2016 — AVEA Standard with Compressor ventilator-refurbished, R17312-xx (xx = 0-14) A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Z-1894-2016 — TCA Board, 16542A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Z-1895-2016 — Gas Delivery Engine (GDE)-1st Generation, 16222-001-99 A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Z-1896-2016 — Gas Delivery Engine (GDE), 16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Z-1897-2016 — Gas Delivery Engine (GDE)-refurbished, R16650A A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Z-1898-2016 — AVEA GDE/UIM upgrade kit, 12283-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Z-1899-2016 — AVEA GDE upgrade kit, 12284-PMN A continuous ventilator intended to mechanically control or assist broad spectrum patient breathing by delivering a predetermined percentage of oxygen in the breathing gas.
- Z-2273-2013 — Product Name: AVEA¿ Ventilator. All Models. The affected devices are cleared under K073069 pm 1/25/2008 and K103211 on 05/06/2011. This device is a Class II medical Device. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K013642.
Data sourced from openFDA. This site is unofficial and independent of the FDA.