SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
FDA 510(k) clearance K242269 · decided 2024-11-01
Clearance details
- K-number
- K242269
- Device name
- SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC-14656); Blood Tube Set (SC-14651)
- Applicant
- Quanta Dialysis Technologies, Ltd.
- Decision
- Substantially Equivalent
- Date received
- 2024-08-01
- Decision date
- 2024-11-01
- Days to decision
- 92 days
- Clearance type
- Traditional
- Product code
- ONW
- Device class
- 2
- Regulation number
- 876.5860
- Medical specialty
- Gastroenterology, Urology
- Advisory committee
- Gastroenterology, Urology
- Location
- Warwick, GB
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Quanta Dialysis Technologies
The Builder collects up to 8 candidate devices side by side with yours, then exports the substantial-equivalence comparison scaffold. How it works
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 |
|---|---|---|
| 2008K@HOME HEMODIALYSIS MACHINE (K124035) | Fresenius Medical Care North America | 2013-07-03 |
| FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETNESS DETECTOR (WETALERT) (K121421) | Fresenius Medical Care North America, Design Cente | 2013-01-17 |
| FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR (K070049) | Fresenius Medical Care North America | 2011-02-03 |
Recalls involving this device
No recalls on record reference this clearance.