Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Specialized Health 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) |
|---|---|---|---|---|---|
| K050023 | SECURELOC; ADVANCINTRODUCER | Specialized Health Products, Inc. | 2005-02-18 | 44 | 0 |
| K013394 | LIFTLOC SAFETY INFUSION SET | Specialized Health Products, Inc. | 2001-11-08 | 24 | 1 |
| K964042 | EXTRESAFE PHLEBOTOMY | Specialized Health Products, Inc. | 1997-06-06 | 241 | 0 |
| K962149 | SAFETY CRADLE | Specialized Health Products, Inc. | 1996-10-11 | 129 | 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