510(k) Report

FDA applicant

Sedation Systems, LLC

Clearwater, FL1 decision2017–20171 recall

FDA records 1 decision for Sedation Systems, LLC (Clearwater, FL) in 2017: 1 510(k) clearance. All are in product code CBN (Apparatus, Gas-Scavenging). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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, anesthesiology panel, where it files most

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

FDA decisions per year

1in 2017

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

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2017high 1 (2023) · low 0 (2017)2026

Class I Class II/III not classified

FIG. 1 — Sedation Systems, LLC 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?

  • CBNApparatus, Gas-Scavenging1decision

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?

  • K160950MiniscavSedation Systems, LLC · 20171 recall

The one decision as Sedation Systems, LLC →

What has been recalled?

1 recall linked to its devices; the latest:

  • K160950MINISCAV (tm) Vacuum PumpAug 23, 2023Class II