# Bluepoint Medical GmbH & Co. KG

- Location (FDA's records): Selmsdorf, DE
- FDA decisions: 2 (2017–2019): 2 510(k) clearances
- Product codes: DQA (1), CCK (1)
- Predicates its devices cite: 3 (0 its own); citations of its devices by later devices: 0 (0 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
- Nellcor Puritan Bennett, Inc.: 1 (https://510kreport.com/company/nellcor-puritan-bennett)
- Sentec AG: 1 (https://510kreport.com/company/sentec)
- GE Healthcare: 1 (https://510kreport.com/company/ge-healthcare)

## Recent decisions
- K190824: Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 2m/7ft, Airway Gas Sampling Set, disposable, Infant, TPE, 2m/7ft, Airway Adapter with Luer Connector, Adult/Pediatric (Dec 18, 2019)
- K162014: Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care (same sensor as above, Home Use Guide incl.), Nellcor Flexible SpO2 Sensor, Small, Home Care (same sensor as above, Home Use Guide incl.) (Feb 6, 2017)

Source page: https://510kreport.com/company/bluepoint-medical