# Heidelberg Engineering GmbH

- Location (FDA's records): Heidelberg, DE
- FDA decisions: 27 (1991–2026): 27 510(k) clearances
- Names in FDA's records: Heidelberg Engineering GmbH (18); Heidelberg Engineering (9)
- Product codes: OBO (20), HLI (5), MXK (2)
- 510(k) review time since 2016: median 163 days, against 141 for FDA's reviews in the same codes and years (5 of 12 faster)
- Predicates its devices cite: 31 (20 its own); citations of its devices by later devices: 32 (20 its own)
- Recalls linked to its devices: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Carl Zeiss Meditec, AG: 3 (https://510kreport.com/company/carl-zeiss-meditec)
- Optovue, Inc.: 2 (https://510kreport.com/company/optovue)
- Medivision Medical Imaging, Ltd.: 2 (https://510kreport.com/company/medivision-medical-imaging)
- Bioptigen, Inc.: 1 (https://510kreport.com/company/bioptigen)
- Nidek Technologies Srl: 1 (https://510kreport.com/company/nidek-technologies)
- Carl Zeiss Ophthalmic Systems, Inc.: 1 (https://510kreport.com/company/carl-zeiss-ophthalmic-systems)
- Haag-Streit Holding AG: 1 (https://510kreport.com/company/haag-streit-holding)

## Firms that cite its devices most
- Optos Plc.: 2 (https://510kreport.com/company/optos)
- Optical Imaging, Ltd.: 1 (https://510kreport.com/company/optical-imaging)
- Talia Technology, Ltd.: 1 (https://510kreport.com/company/talia-technology)
- Ophthalmic Technologies, Inc.: 1 (https://510kreport.com/company/ophthalmic-technologies)
- Nidek, Inc.: 1 (https://510kreport.com/company/nidek)
- Notal Vision, Inc.: 1 (https://510kreport.com/company/notal-vision)
- Carl Zeiss Meditec, AG: 1 (https://510kreport.com/company/carl-zeiss-meditec)
- Novadaq Technologies, Inc.: 1 (https://510kreport.com/company/novadaq-technologies)

## Its most-cited devices
- K971671: Heidelberg Retina Angiograph FA/Icga (Hra/C) (1997), cited by 4
- K172649: Spectralis HRA + OCT and variants, Spectralis FA+OCT, Spectralis ICGA+OCT, Spectralis OCT Blue Peak, Spectralis OCT with Multicolor (2017), cited by 3
- K101223: Spectralis Hra+Oct, Spectralis FA_Oct, Spectralis Icga+ Oct, Spectralis Hra, Spectralis FA (2010), cited by 3
- K223557: SPECTRALIS HRA+OCT and variants (2023), cited by 2
- K943955: Retina Flowmeter (1994), cited by 2
- K063191: Heidelberg Retina Angiograph 2/Optical Coherence Tomograph, Model Hra 2/Oct (2006), cited by 2

## Recent decisions
- K261019: Anterion (Sep 11, 2026)
- K253837: SPECTRALIS HRA+OCT and variants; SPECTRALIS with Flex Module (May 7, 2026)
- K250868: SPECTRALIS HRA+OCT and variants (May 12, 2025)
- K240924: Anterion (Dec 13, 2024)
- K241163: SPECTRALIS with Flex Module (Oct 11, 2024)
- K240221: SPECTRALIS HRA+OCT and variants (Jul 1, 2024)
- K223557: SPECTRALIS HRA+OCT and variants (Oct 20, 2023)
- K230897: Anterion (Oct 11, 2023)

Source page: https://510kreport.com/company/heidelberg-engineering