Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Dr. Bruno Lange GmbH · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
199 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K834226 | FLAME PHOTOMETERS | Dr. Bruno Lange GmbH | 1984-06-22 | 199 | 0 |
| K832531 | PHOTOMETER LP 300 | Dr. Bruno Lange GmbH | 1983-12-12 | 136 | 0 |
| K801563 | PHOTOMETER LP 3 | Dr. Bruno Lange GmbH | 1980-08-20 | 43 | 0 |
| K801562 | PHOTOMETER LP 6 | Dr. Bruno Lange GmbH | 1980-08-20 | 43 | 0 |
| K801564 | PHOTOMETER LP 1 | Dr. Bruno Lange GmbH | 1980-08-20 | 43 | 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