Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Ibl GmbH — Predicate Candidate Screening
6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
105 daysmedian FDA review time
127 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K051969 | TRICAT RIA (ADRENALIN/NORADRENALIN/DOPAMINE); KATCOMBI RIA ( | Ibl GmbH | 2005-10-03 | 75 | 0 |
| K041349 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF ESTRADIOL I | Ibl GmbH | 2004-09-24 | 127 | 0 |
| K040923 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF PROGESTERON | Ibl GmbH | 2004-07-22 | 105 | 0 |
| K033786 | LUMINESCENT IMMUNOASSAY KIT FOR THE DETECTION OF TESTOSTERON | Ibl GmbH | 2004-02-27 | 85 | 0 |
| K032796 | IBL C3D-CIC EIA TEST | Ibl GmbH | 2004-01-13 | 127 | 0 |
| K032254 | IBL C1Q-CIC CIA TEST | Ibl GmbH | 2003-08-29 | 38 | 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