Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Primary Care Solutions, 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) |
|---|---|---|---|---|---|
| K082330 | PRIMARY CARE SOLUTIONS, INC., STERILE WATER AND SALINE FOR I | Primary Care Solutions, Inc. | 2008-10-09 | 56 | 0 |
| K030813 | PRIMARY CARE SOLUTIONS PREFILLED 10CC AND PREFILLED 30CC INF | Primary Care Solutions, Inc. | 2003-05-30 | 77 | 27 |
| K000266 | PRIMARY CARE SOLUTIONS STERILE SALINE-0.9% SODIUM CHLORIDE F | Primary Care Solutions, Inc. | 2001-07-12 | 531 | 0 |
| K000265 | PRIMARY CARE SOLUTIONS STERILE WATER DEVICE IRRIGATION | Primary Care Solutions, Inc. | 2001-07-12 | 531 | 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