Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Goosen Enterprises, Inc. · Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K923848 | GOOSEN SELF-LUBRICATING CATHETER | Goosen Enterprises, Inc. | 1994-02-18 | 567 | 0 |
| K896134 | ACUFLO, VACUUM-POWERED BODY FLUID SUCTION APPARA. | Goosen Enterprises, Inc. | 1990-08-30 | 310 | 0 |
| K896579 | GOOSEN URINARY DRAINAGE SYSTEM | Goosen Enterprises, Inc. | 1990-02-15 | 87 | 0 |
| K844889 | MENSINK-GOOSEN CATHETER | Goosen Enterprises, Inc. | 1985-03-18 | 91 | 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