# Heine Optotechnik GmbH & Co. KG

- Location (FDA's records): Herrsching, DE
- FDA decisions: 7 (2010–2015): 7 510(k) clearances
- Product codes: HLJ (5), DXQ (1), HLI (1)
- Predicates its devices cite: 12 (4 its own); citations of its devices by later devices: 5 (4 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Rudolf Riester GmbH & Co. KG: 4 (https://510kreport.com/company/rudolf-riester)
- Kirchner & Wilhelm GmbH + Co.Kg: 1 (https://510kreport.com/company/kirchner-wilhelm)
- Keeler Instruments, Inc.: 1 (https://510kreport.com/company/keeler-instruments)
- Neitz Instruments Company, Ltd.: 1 (https://510kreport.com/company/neitz-instruments)
- Welch Allyn, Inc.: 1 (https://510kreport.com/company/welch-allyn)

## Firms that cite its devices most
- Propper Manufacturing Co., Inc.: 1 (https://510kreport.com/company/propper-manufacturing)

## Its most-cited devices
- K123587: Heine Mini 3000 Led Ophthalmoscope (2013), cited by 3
- K123316: Heine Omega 500 (2013), cited by 2

## Recent decisions
- K142486: Heine Beta 200, Heine Beta 200 S, Heine K 180 (May 18, 2015)
- K142837: Heine Sigma 250 & Heine Sigma 250 M2 (Jan 29, 2015)
- K131959: Heine Mini 3000(R) Ophthalmoscope (Mar 7, 2014)
- K131961: Heine Beta 200(R) Ophthalmoscope (Dec 4, 2013)
- K123587: Heine Mini 3000 Led Ophthalmoscope (Mar 22, 2013)
- K123316: Heine Omega 500 (Feb 26, 2013)
- 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- (Aug 27, 2010)

Source page: https://510kreport.com/company/heine-optotechnik