Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Profile Therapeutics Plc — Predicate Candidate Screening
3 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K052941 | I-NEB INSIGHT AAD SYSTEM | Profile Therapeutics Plc | 2005-12-09 | 50 | 0 |
| K042991 | I-NEB AAD SYSTEM | Profile Therapeutics Plc | 2005-09-23 | 326 | 0 |
| K030747 | PRODOSE AAD SYSTEM | Profile Therapeutics Plc | 2004-04-22 | 409 | 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