Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Patient Solutions, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
86 daysmedian FDA review time
199 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K964384 | MODEL D-290P ADMINISTRATION SET | Patient Solutions, Inc. | 1997-01-27 | 84 | 0 |
| K961263 | MODEL 1200 ABMULATORY INFUSION PUMP | Patient Solutions, Inc. | 1996-08-23 | 143 | 0 |
| K954841 | MODEL D-285N ADMINISTRATION SET | Patient Solutions, Inc. | 1995-12-11 | 49 | 0 |
| K953270 | MODEL 1100 MEDMATE INFUSION PUMP | Patient Solutions, Inc. | 1995-10-07 | 86 | 0 |
| K894028 | AMBULATORY INFUSION SYSTEM AND ACCESSORIES | Patient Solutions, Inc. | 1989-12-22 | 199 | 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