Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ellis Pharmaceutical Consulting, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
98 daysmedian FDA review time
132 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K910936 | EMPTY I.V. CONTAINER | Ellis Pharmaceutical Consulting, Inc. | 1991-07-16 | 132 | 0 |
| K884233 | QUADROJECT(TM) | Ellis Pharmaceutical Consulting, Inc. | 1989-01-30 | 115 | 0 |
| K852235 | STERETS INJECTION SWAB | Ellis Pharmaceutical Consulting, Inc. | 1985-06-07 | 16 | 0 |
| K844180 | THE MCP-70-SE SYSTEM | Ellis Pharmaceutical Consulting, Inc. | 1985-02-01 | 98 | 0 |
| K832789 | AFTER LOADING BUCHLER | Ellis Pharmaceutical Consulting, Inc. | 1983-09-29 | 45 | 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