FDA applicant

Heine Optotechnik GmbH & Co. KG

Herrsching, DE7 decisions2010–20150 recalls

FDA records 7 decisions for Heine Optotechnik GmbH & Co. KG (Herrsching, DE) from 2010 to 2015: 7 510(k) clearances. Most are in product codes HLJ (Ophthalmoscope, Battery-Powered) and DXQ (Blood Pressure Cuff). Its devices cite 12 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, ophthalmic panel, where it files most

How often FDA has decided Heine Optotechnik GmbH & Co. KG’s devices, and how often a recall has named them.

FDA decisions per year

2in 2015

2010high 3 (2013) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Heine Optotechnik GmbH & Co. KG by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Heine Optotechnik GmbH & Co. KG’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Other applicant names beginning “Heine”

FDA records each applicant name separately; these may or may not be the same firm.

Heine USA, Ltd. 1

Heine Optotechnik GmbH & Co. KG

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Heine”