DOSI FLOW
FDA 510(k) clearance K851058 · decided 1985-04-29
Clearance details
- K-number
- K851058
- Device name
- DOSI FLOW
- Applicant
- Leventon, S.A.
- Decision
- Substantially Equivalent
- Date received
- 1985-03-14
- Decision date
- 1985-04-29
- Days to decision
- 46 days
- Clearance type
- Traditional
- Product code
- LDR
- Device class
- 2
- Regulation number
- 880.5725
- Medical specialty
- General Hospital
- Advisory committee
- General Hospital
- Location
- Barcelona, ES
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Leventon
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 |
|---|---|---|
| DEKA Infusion System, DEKA Administration Set (K242693) | Deka Research and Development Corporation | 2024-10-07 |
| DEKA Infusion System, DEKA Administration Set (K232316) | Deka Research and Development | 2024-03-01 |
| Volumetric Infusion Controller (K153760) | DEKA Research & Development | 2016-10-03 |
| PACER MODEL 100 INFUSION CONTROLLER (K963136) | Health Watch, Inc. | 1997-10-10 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500-3P (K971865) | Alexander Mfg. Co. | 1997-07-03 |
| ALEXANDER MANUFACTURING CO. RECHARGEABLE BATTERY PART NUMBER M12/500 (K971826) | Alexander Mfg. Co. | 1997-07-03 |
| UNIVERSAL CONTROLLER, MODEL 100 (K934543) | Metamed, Inc. | 1994-03-29 |
| FLOW CONTROLLING EXTENSION SET (K935236) | Block Medical, Inc. | 1994-02-24 |
| MASTER FLOW I.V. PUMPETTE (K905497) | The Master Medical Corp. | 1991-04-16 |
| STAT 2 IV PUMPETTE (K905498) | The Master Medical Corp. | 1991-04-16 |
| 3M IV FLOW REGULATOR (K896907) | 3M Company | 1990-02-26 |
| VARI-SET (K894111) | Sonex Medical | 1989-09-28 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| "***DOSI-FLOW 1 I.V. EXTENSION SET WITH I.V. FLOW REGULATOR REGULADOR DE CAUDAL PARA SETS recall (Z-2601-2011) | Leventon S. A. U. | 2011-06-21 |