HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
FDA 510(k) clearance K872364 · decided 1987-10-13
Clearance details
- K-number
- K872364
- Device name
- HEMODIALYSIS (SPS), MODEL 550, CODE 5M1309
- Applicant
- Travenol Laboratories, S.A.
- Decision
- Substantially Equivalent
- Date received
- 1987-06-18
- Decision date
- 1987-10-13
- Days to decision
- 117 days
- Clearance type
- Traditional
- Product code
- FII
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Round Lake, IL, 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 |
|---|---|---|
| NXSTAGE SYSTEM ONE (K030470) | Nxstage Medical, Inc. | 2003-07-07 |
| GAMBRO MULTIPURPOSE SYSTEM MPS-10 (K881270) | Gambro, Inc. | 1988-08-24 |
| HEMOFILTRATION SYSTEM 10 (K862716) | Gambro, Inc. | 1986-09-09 |
| COTRAL I W/4.5 L/HR. ULTRAFILTRAT. CAPA (K822386) | Hospal Medical Corp. | 1982-10-06 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| System 1000 family of Hemodialysis Instruments, including the System 1000, Arena, 1550, BM recall (Z-0367-05) | Baxter Healthcare Renal Div | 2004-12-24 |
| Baxter SPS 550 Single Patient System Hemodialysis Machine; Baxter Healthcare Corporation, recall (Z-0660-03) | Baxter Healthcare Corp. | 2003-03-20 |