Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ncs Lab Srl — 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) |
|---|---|---|---|---|---|
| K220994 | Shoulder PacemakerTM | Ncs Lab Srl | 2022-10-14 | 193 | 0 |
| K210674 | Shoulder Pacemaker | Ncs Lab Srl | 2021-08-24 | 172 | 0 |
| K160500 | Elite SPK, Compasso, Elite SPK Kit | Ncs Lab Srl | 2016-04-20 | 57 | 0 |
| K120356 | NCS FISH-FIT MD SYSTEM FISH-FIT MD COMPASS MD | Ncs Lab Srl | 2012-12-11 | 309 | 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