Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Solopak Medical Products, Inc. · 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) |
|---|---|---|---|---|---|
| K970800 | MAXCESS NEEDLEFREE - Y- SITE (100713) | Solopak Medical Products, Inc. | 1997-04-02 | 29 | 0 |
| K962663 | SOLOPAK SIDEKICK INFUSION PUMP AND ADMINISTATION SET | Solopak Medical Products, Inc. | 1996-10-04 | 88 | 0 |
| K963355 | SOLOPAK PARAGON INFUSOR PUMP AND INFUSION SET | Solopak Medical Products, Inc. | 1996-10-04 | 39 | 0 |
| K960661 | MAXCESS NEEDLE FREE CONNECTOR (8200) | Solopak Medical Products, Inc. | 1996-03-21 | 34 | 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