Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
P/L Biomedical — 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) |
|---|---|---|---|---|---|
| K122969 | CLICKFINE PEN NEEDLE | P/L Biomedical | 2012-10-25 | 29 | 0 |
| K122971 | CLICKFINE PEN NEEDLE | P/L Biomedical | 2012-10-25 | 29 | 0 |
| K972135 | MAERSK MEDICAL PURELINE COMFORT SUBCUTANEOUS INFUSION SET | P/L Biomedical | 1997-08-26 | 81 | 12 |
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