BIPAP SYNCHRONY 2
FDA 510(k) clearance K092043 · decided 2009-08-05
Clearance details
- K-number
- K092043
- Device name
- BIPAP SYNCHRONY 2
- Applicant
- Respironics, Inc.
- Decision
- Substantially Equivalent
- Date received
- 2009-07-06
- Decision date
- 2009-08-05
- Days to decision
- 30 days
- Clearance type
- Special
- Product code
- MNS
- Device class
- 2
- Regulation number
- 868.5895
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murrysville, PA, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Respironics
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| myAir (K251889) | Resmed Corp | 2026-04-08 |
| BreathePal Bilevel (GFM50-MD2201) (K252078) | Compal Electronics, Inc. | 2026-03-17 |
| Mariana Minerva; Mariana Nimbus (K251661) | Resmed Pty , Ltd. | 2026-02-23 |
| Vivo 1, Vivo 2 (K240778) | Breas Medical AB | 2024-12-13 |
| ReddyPort Elbow (K231064) | Smd Manufacturing, LLC | 2023-07-13 |
| BPAP System (K213169) | BMC Medical Co., Ltd. | 2022-12-05 |
| ReddyPort NIV Access Elbow (K171827) | Smd Manufacturing, LLC | 2018-01-19 |
| Juno VPAP ST-A (K161492) | Resmed, Ltd. | 2017-01-19 |
| VPAP Adapt SV, VPAP Tx, S9 VPAP Tx (K161487) | Resmed, Ltd. | 2016-09-09 |
| Juno VPAP ST-A (K153061) | Resmed, Ltd. | 2016-04-13 |
| EASYCARE ONLINE (K132371) | Resmed, Ltd. | 2013-11-22 |
| S9 VPAP TX (K123511) | Resmed, Ltd. | 2013-03-21 |
Recalls involving this device
No recalls on record reference this clearance.