510(k) Report

FDA applicant

Synergen Technology Labs, LLC

Dallas, TX2 decisions2018–20260 recalls

FDA records 2 decisions for Synergen Technology Labs, LLC (Dallas, TX) from 2018 to 2026: 2 510(k) clearances. Most are in product codes DRG (Transmitters And Receivers, Physiological…) and DQK (Computer, Diagnostic, Programmable). 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 Synergen Technology Labs, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2018: 12026 (partial year): 1
2018high 1 (2018) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2018.

FIG. 1 — Synergen Technology Labs, LLC by year, 2018–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • DRGTransmitters And Receivers, Physiological Signal, Radiofrequency1decision
  • DQKComputer, Diagnostic, Programmable1decision

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?

  • K252978ScioCardio ECG Analysis PlatformSynergen Technology Labs, LLC · 2026
  • K171019ScioCardio ECG TransmitterSynergen Technology Labs, LLC · 2018

All 2 as Synergen Technology Labs, LLC →