Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QJZ — 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) |
|---|---|---|---|---|---|
| K261335 | VitalFlow Set with Balance™ Biosurface | Medtronic, Inc. | 2026-07-31 | 99 | 0 |
| K240880 | VitalFlow Set with Balance Biosurface | Medtronic, Inc. | 2024-09-12 | 164 | 0 |
| K232926 | Novalung ultimate kit (US) | Fresenius Medical Care Renal Therapies Group, LLC | 2024-04-15 | 208 | 0 |
| K191407 | Novalung System | Fresenius Medical Care Renal Therapies Group, LLC | 2020-02-21 | 269 | 1 |
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