Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Erie Medical — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
266 daysmedian FDA review time
421 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861865 | ERIE-NEB | Erie Medical | 1986-07-01 | 47 | 0 |
| K853051 | TRACHEAL TUBES | Erie Medical | 1986-04-11 | 266 | 0 |
| K853039 | PRESSURE REGULATOR | Erie Medical | 1986-04-11 | 266 | 0 |
| K853040 | PRESSURE GAUGE | Erie Medical | 1985-10-10 | 83 | 0 |
| K832466 | TRACHEAL TUBE 16 GAUGE-1.65MM- | Erie Medical | 1984-09-19 | 421 | 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