510(k) Report

FDA applicant

Fsc Laboratories, Inc.

Charlotte, NC1 decision2014–20141 recall

FDA records 1 decision for Fsc Laboratories, Inc. (Charlotte, NC) in 2014: 1 510(k) clearance. All are in product code NVP (Holding Chambers, Direct Patient Interface). 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 Fsc Laboratories, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2014: 1
2014high 1 (2014) · low 0 (2015)2026

2026 so far, outlined.

Recalls per year

1in 2016

2016: 1
2014high 1 (2016) · low 0 (2014)2026

Class I Class II/III not classified

FIG. 1 — Fsc Laboratories, Inc. by year, 2014–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • NVPHolding Chambers, Direct Patient Interface1decision

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?

  • K140062FSC Anti-Static Valved Collapsible Holding ChamberFsc Laboratories, Inc. · 20141 recall

The one decision as Fsc Laboratories, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K140062Flexichamber Anti-Static Valved Collapsible Holding Chamber, used by patients to…May 16, 2016Class II