510(k) Report

FDA applicant

Bluepoint Medical GmbH & Co. KG

Selmsdorf, DE2 decisions2017–20190 recalls

FDA records 2 decisions for Bluepoint Medical GmbH & Co. KG (Selmsdorf, DE) from 2017 to 2019: 2 510(k) clearances. Most are in product codes DQA (Oximeter) and CCK (Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase). Its devices cite 3 predicates, 0 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, cardiovascular panel, where it files most

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

FDA decisions per year

1in 2019

2017: 12019: 1
2017high 1 (2017) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Bluepoint Medical GmbH & Co. KG by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DQAOximeter1decision
  • CCKAnalyzer, Gas, Carbon-Dioxide, Gaseous-Phase1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K190824Airway Gas Sampling Set, disposable, Adult/Pediatric, TPE, 3m/10ft, Airway Gas Sampling Set, disposable…Bluepoint Medical GmbH & Co. KG · 2019
  • K162014Nellcor Flexible SpO2 Sensor, Nellcor Flexible SpO2 Sensor, Small, Nellcor Flexible SpO2 Sensor, Home Care…Bluepoint Medical GmbH & Co. KG · 2017

All 2 as Bluepoint Medical GmbH & Co. KG →