TRILOGY 200 VENTILATOR
FDA 510(k) clearance K093416 · decided 2010-01-29
Clearance details
- K-number
- K093416
- Device name
- TRILOGY 200 VENTILATOR
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-11-02
- Decision date
- 2010-01-29
- Days to decision
- 88 days
- Clearance type
- Traditional
- Product code
- CBK
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Philips Trilogy 200 Ventilator, Model Numbers 1040005, U1040005, 1040005B, U1040005B, CA10 recall (Z-0883-2023) | Philips Respironics, Inc. | 2023-01-06 |
| Trilogy 100, Trilogy 200, Garbin Plus, Aeris, LifeVent Continuous Ventilators. recall (Z-1956-2021) | Philips Respironics, Inc. | 2021-07-15 |
| Trilogy 100, Trilogy 200, Trilogy O2, Trilogy 202, Trilogy EC, Garbin, Garbin Plus Trilogy recall (Z-1065-2016) | Philips Respironics | 2016-03-07 |
| Trilogy Ventilators The Respironics Trilogy 100 system provides continuous or intermittent recall (Z-1143-2014) | Phillips Respironics, Inc. | 2014-03-06 |
| Respironics Trilogy 100, 200, and 202 Ventilators The Respironics Trilogy systems provides recall (Z-2024-2012) | Respironics, Inc. | 2012-07-23 |