Novalung System
FDA 510(k) clearance K191407 · decided 2020-02-21
Clearance details
- K-number
- K191407
- Device name
- Novalung System
- Applicant
- Fresenius Medical Care Renal Therapies Group, LLC
- Decision
- Substantially Equivalent
- Date received
- 2019-05-28
- Decision date
- 2020-02-21
- Days to decision
- 269 days
- Clearance type
- Traditional
- Product code
- QJZ
- Device class
- 2
- Regulation number
- 870.4100
- Medical specialty
- Cardiovascular
- Advisory committee
- Cardiovascular
- Location
- Waltham, MA, 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 |
|---|---|---|
| VitalFlow Set with Balance™ Biosurface (K261335) | Medtronic, Inc. | 2026-07-31 |
| VitalFlow Set with Balance Biosurface (K240880) | Medtronic, Inc. | 2024-09-12 |
| Novalung ultimate kit (US) (K232926) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-04-15 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Novalung sensor box is a component of the Novalung Console (F30000162)-Indicated for long- recall (Z-1822-2024) | Fresenius Medical Care Holdings, Inc. | 2024-05-15 |