Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Lifemed of California · 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) |
|---|---|---|---|---|---|
| K001329 | INTRAVASCULAR IV SET, IV SET WITH BURETTE, EXTENSION SET | Lifemed of California | 2001-02-14 | 293 | 0 |
| K903502 | LIFECOIL CATHETER | Lifemed of California | 1990-10-22 | 80 | 0 |
| K841929 | LIFEMED LIFECOIL CATHETERS | Lifemed of California | 1984-08-08 | 90 | 0 |
| K821624 | LOW VOLUME INFUSTION SET | Lifemed of California | 1982-06-22 | 20 | 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