Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
KTA · Predicate Candidate Screening
8 FDA 510(k) clearances under this product code; the 50 most recent screened below.
45 daysmedian FDA review time
91 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K800843 | MEDEFIZZ A & MEDEFIZZ B | Medefield Pty. , Ltd. | 1980-06-17 | 63 | 0 |
| K800840 | MEDEFOAM-2 | Medefield Pty. , Ltd. | 1980-06-17 | 63 | 0 |
| K800459 | BARIUM SULFATE, USP IN SUSPENSION | Central Pharmaceuticals, Inc. | 1980-05-30 | 91 | 0 |
| K800841 | MEDEBAR M | Medefield Pty. , Ltd. | 1980-05-30 | 45 | 0 |
| K800842 | MEDEBAR XAC-90 | Medefield Pty. , Ltd. | 1980-05-30 | 45 | 0 |
| K800839 | MEDESCAN | Medefield Pty. , Ltd. | 1980-05-30 | 45 | 0 |
| K800844 | MEDEBAR XL | Medefield Pty. , Ltd. | 1980-05-30 | 45 | 0 |
| K760736 | BARIMEX, BARIUM SULFATE COMPOUND | C.R. Bard, Inc. | 1976-11-09 | 42 | 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