Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ferno-Washington, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
78 daysmedian FDA review time
114 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K980033 | FERNO HEALTHCARE RECLINE-A-BATH 2 | Ferno-Washington, Inc. | 1998-04-21 | 106 | 0 |
| K932417 | FERNO WASHINGTON INCUBATOR TRANSPORTER, MOD. 35-IT | Ferno-Washington, Inc. | 1993-09-09 | 114 | 0 |
| K864765 | MODEL 668, TRACTION SPLINT, ADULT | Ferno-Washington, Inc. | 1986-12-17 | 12 | 0 |
| K864269 | MODEL 35-B ALL LEVEL COT | Ferno-Washington, Inc. | 1986-11-13 | 15 | 0 |
| K862441 | EZ LOAD MODEL 30, ALL LEVEL COT | Ferno-Washington, Inc. | 1986-09-12 | 78 | 2 |
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