Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
Heine Optotechnik GmbH & Co. KG · Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
124 daysmedian FDA review time
256 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K142486 | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 | Heine Optotechnik GmbH & Co. KG | 2015-05-18 | 256 | 0 |
| K142837 | HEINE SIGMA 250 & HEINE SIGMA 250 M2 | Heine Optotechnik GmbH & Co. KG | 2015-01-29 | 121 | 0 |
| K131959 | HEINE MINI 3000(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | 2014-03-07 | 253 | 0 |
| K131961 | HEINE BETA 200(R) OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | 2013-12-04 | 160 | 0 |
| K123587 | HEINE MINI 3000 LED OPHTHALMOSCOPE | Heine Optotechnik GmbH & Co. KG | 2013-03-22 | 121 | 0 |
| K123316 | HEINE OMEGA 500 | Heine Optotechnik GmbH & Co. KG | 2013-02-26 | 124 | 0 |
| K101892 | HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA | Heine Optotechnik GmbH & Co. KG | 2010-08-27 | 51 | 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