Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Lyphomed, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
91 daysmedian FDA review time
120 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910142 | SPARK KIT(R), MODIFICATION | Lyphomed, Inc. | 1991-05-14 | 120 | 0 |
| K864509 | SPARK-KIT(TM) | Lyphomed, Inc. | 1987-02-18 | 96 | 0 |
| K853019 | NITROGLYCERIN INFUSION SET | Lyphomed, Inc. | 1985-11-12 | 118 | 0 |
| K853086 | SECONDARY ADMINISTRATION SET | Lyphomed, Inc. | 1985-08-19 | 27 | 0 |
| K852882 | MAXIFILL TRANSFER SET | Lyphomed, Inc. | 1985-08-16 | 38 | 0 |
| K852881 | VENTED SECONDARY IV ADMINISTRATION SET | Lyphomed, Inc. | 1985-08-16 | 38 | 0 |
| K842678 | I.V. TRANSFER SPIKE | Lyphomed, Inc. | 1984-10-09 | 91 | 0 |
| K842345 | MAXIFILL TRANSFER SET | Lyphomed, Inc. | 1984-08-17 | 64 | 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