Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
GBA · Predicate Candidate Screening
5 FDA 510(k) clearances under this product code; the 50 most recent screened below.
78 daysmedian FDA review time
141 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K861877 | BYRON WORD BARTHOLIAN GLAND CATHETER | Byron Medical | 1986-05-30 | 15 | 0 |
| K802025 | BALLOON RETENTION CHEST CATHETER | Loseff Medical Designers, Ltd. | 1980-09-26 | 37 | 0 |
| K790444 | ELECATH MULTI-PURPOSE ARTERIAL SURGER | Electro-Catheter Corp. | 1979-06-11 | 97 | 0 |
| K781772 | CATHETER, TRANSLUMINAL BALLOON | Medi-Tech, Inc. | 1979-03-06 | 141 | 0 |
| K781665 | TUBE, LEATHERMAN/IMBRUCE | National Catheter Co. Div. Mallinckrodt | 1978-12-15 | 78 | 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