PRESSURE REGULATOR/Y CONNECTOR
FDA 510(k) clearance K852649 · decided 1985-08-02
Clearance details
- K-number
- K852649
- Device name
- PRESSURE REGULATOR/Y CONNECTOR
- Applicant
- C.R. Bard, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1985-06-21
- Decision date
- 1985-08-02
- Days to decision
- 42 days
- Clearance type
- Traditional
- Product code
- CAN
- Device class
- 1
- Regulation number
- 868.2700
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Murray Hill, NJ, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| MR Conditional CGA 870 (K162811) | Essex Industries, Inc. | 2017-03-02 |
| PORTABLE OXYGEN UNIT SCA900 (K080243) | San Cheong Co. , Ltd. | 2009-04-07 |
| REMCORE REMOTE CONTROLLED OXYGEN REGULATOR (K060265) | Remcore, Inc. | 2006-10-25 |
| CYL-FIL OXYGEN SYSTEM (K061785) | Responsive Respiratory, Inc. | 2006-09-07 |
| OXYGEN REGULATOR (K950777) | Mada Medical Products, Inc. | 1995-04-14 |
| VANGUARD SERIES GAS REGULATORS (K942751) | Buckman Co., Inc. | 1995-02-09 |
| LSPI PRESSURE REGULATOR (K936187) | Life Support Products, Inc. | 1994-01-27 |
| 1500 SERIES REGULATOR (K932006) | Precision Medical, Inc. | 1993-10-25 |
| AMBU OXYGEN REGULATOR (K921125) | Amg, LLC | 1992-09-17 |
| GAMBRO ENGSTROM Y FILTER PKG. ALONE W/ VAR.MODELS (K915154) | C.G.H. Medical, Inc. | 1992-05-27 |
| REGULATOR FLOWMETER (K915505) | Lifeguard Medical Products, Inc. | 1992-04-22 |
| GAMBRO ENGSTROM Y-FILTER WITH EDITH FLEX (1500F) (K914271) | C.G.H. Medical, Inc. | 1992-04-13 |
Recalls involving this device
No recalls on record reference this clearance.
PMA approvals by this applicant
| Record | Firm | Date |
|---|---|---|
| Covera Vascular Covered Stent (P170042/S014) | C.R. Bard, Inc. | 2025-12-16 |
| Covera Vascular Covered Stents (P170042/S013) | C.R. Bard, Inc. | 2025-06-26 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S033) | C.R. Bard, Inc. | 2025-03-13 |
| AVITENE MICROFIBRILLAR COLLAGEN HEMOSTAT NON-WOVEN WEB (P800002/S032) | C.R. Bard, Inc. | 2025-02-18 |
| Avitene Bulk Flour Cleanroom Expansion (P800002/S031) | C.R. Bard, Inc. | 2024-01-18 |
| Avitene Microfibrillar Collagen Hemostat (P800002/S030) | C.R. Bard, Inc. | 2023-10-04 |
| Covera Vascular Covered Stent (P170042/S012) | C.R. Bard, Inc. | 2023-02-02 |
| Avitene Microfibrillar Collagen Hemostat (MCH) Non-Woven Web and Avitene Microfibrillar Collagen Hemostat (MCH) EndoAvit (P800002/S027) | C.R. Bard, Inc. | 2022-04-01 |