Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Quanta Dialysis Technologies, Ltd. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K242269 | SC+ Hemodialysis Device (SC-14269); Dialysate Cartridge (SC- | Quanta Dialysis Technologies, Ltd. | 2024-11-01 | 92 | 0 |
| K222067 | SC+ Hemodialysis Device, SC+ Dialysate Cartridge, SC+ Blood | Quanta Dialysis Technologies, Ltd. | 2022-11-10 | 120 | 0 |
| K210661 | SC+ Hemodialysis Machine, SC+ Dialysate Cartridge, SC+ Blood | Quanta Dialysis Technologies, Ltd. | 2021-08-12 | 161 | 0 |
| K193670 | SC+ Haemodialysis Machine, SC+ Dialysate Cartridge, SC+ Bloo | Quanta Dialysis Technologies, Ltd. | 2020-12-23 | 358 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams: atlasbyauro.com/fda