510(k) Report

FDA applicant

Simergent, LLC

Oklahoma City, OK1 decision2025–20250 recalls

FDA records 1 decision for Simergent, LLC (Oklahoma City, OK) in 2025: 1 510(k) clearance. All are in product code FKX (System, Peritoneal, Automatic Delivery). Its devices cite 2 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, gastroenterology and urology panel, where it files most

How often FDA has decided Simergent, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2025: 1
2025high 1 (2025)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2025.

FIG. 1 — Simergent, LLC by year, 2025–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FKXSystem, Peritoneal, Automatic Delivery1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K250523Archimedes Pro Automated Peritoneal Dialysis Cycler (3014-00000-1); Archimedes Standard Automated Peritoneal…Simergent, LLC · 2025

The one decision as Simergent, LLC →