Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
ONW · Predicate Candidate Screening
4 FDA 510(k) clearances under this product code; 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 |
| K124035 | 2008K@HOME HEMODIALYSIS MACHINE | Fresenius Medical Care North America | 2013-07-03 | 187 | 0 |
| K121421 | FRESENIUS 2008K HOME HEMODIALYSIS MACHINE WITH WIRELESS WETN | Fresenius Medical Care North America, Design Cente | 2013-01-17 | 248 | 2 |
| K070049 | FRESENIUS 2008K @HOME WITH WIRELESS WETNESS DETECTOR | Fresenius Medical Care North America | 2011-02-03 | 1491 | 7 |
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