Heine Optotechnik GmbH & Co. KG: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Heine Optotechnik GmbH & Co. KG” (first 2010, latest 2015), across 3 product codes in 2 review panels. Median 510(k) review time under this name: 124 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 3 | 124 |
| 2014 | 1 | 253 |
| 2015 | 2 | 188 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HLJ | Ophthalmoscope, Battery-Powered | 5 | 5 |
| DXQ | Blood Pressure Cuff | 1 | 1 |
| HLI | Ophthalmoscope, Ac-Powered | 1 | 1 |
Review panels
- Ophthalmic (6)
- Cardiovascular (1)
Most recent Heine Optotechnik GmbH & Co. KG 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K142486 | HEINE BETA 200, HEINE BETA 200 S, HEINE K 180 | HLJ | 2015-05-18 | 256 |
| K142837 | HEINE SIGMA 250 & HEINE SIGMA 250 M2 | HLJ | 2015-01-29 | 121 |
| K131959 | HEINE MINI 3000(R) OPHTHALMOSCOPE | HLJ | 2014-03-07 | 253 |
| K131961 | HEINE BETA 200(R) OPHTHALMOSCOPE | HLJ | 2013-12-04 | 160 |
| K123587 | HEINE MINI 3000 LED OPHTHALMOSCOPE | HLJ | 2013-03-22 | 121 |
| K123316 | HEINE OMEGA 500 | HLI | 2013-02-26 | 124 |
| K101892 | HEINE GAMMA G7; HEINE GAMMA G5, HEINE GAMMA GP, HEINE GAMMA GST, HEINE GAMMA XXL LF MODEL M-000.09.23X, M-000.09.24X, M- | DXQ | 2010-08-27 | 51 |
Recalls
openFDA lists no recalls under a recalling firm named Heine Optotechnik GmbH & Co. KG.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Heine USA , Ltd. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Heine Optotechnik GmbH & Co. KG?
FDA lists 7 510(k) clearances under the applicant name “Heine Optotechnik GmbH & Co. KG” (first 2010, latest 2015), across 3 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Heine Optotechnik GmbH & Co. KG?
The median time from FDA receipt to decision across 510(k)s cleared under the name Heine Optotechnik GmbH & Co. KG is 124 days.
Which FDA product codes appear under Heine Optotechnik GmbH & Co. KG?
The most frequent FDA product codes under this applicant name are HLJ (Ophthalmoscope, Battery-Powered, 5); DXQ (Blood Pressure Cuff, 1); HLI (Ophthalmoscope, Ac-Powered, 1).
Next steps
- See all 7 Heine Optotechnik GmbH & Co. KG clearances with predicates and recalls
- Run predicate analysis for product code HLJ, Heine Optotechnik GmbH & Co. KG's most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.