Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
East Texas Lighthouse For the Blind · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
21 daysmedian FDA review time
101 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K883376 | STERILIZATION WRAP TYPE 22,44,77 | East Texas Lighthouse For the Blind | 1988-09-28 | 50 | 0 |
| K882275 | STERILE PACK (PROCEDURAL TRAY/KITS) | East Texas Lighthouse For the Blind | 1988-07-18 | 48 | 0 |
| K863733 | TOWEL PACK, SURGICAL | East Texas Lighthouse For the Blind | 1986-10-14 | 21 | 0 |
| K862062 | NONWOVEN SURGICAL DRAPE PACK | East Texas Lighthouse For the Blind | 1986-06-10 | 11 | 0 |
| K850067 | MEDICAL, DISPOSABLE BEDDING | East Texas Lighthouse For the Blind | 1985-04-19 | 101 | 0 |
| K850811 | PAD, PRE-OPERATIVE PREPARATION | East Texas Lighthouse For the Blind | 1985-03-21 | 21 | 0 |
| K850016 | TOWEL PACK, SURGICAL | East Texas Lighthouse For the Blind | 1985-01-23 | 21 | 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