510(k) Report

FDA applicant

Lineage Biomedical, Inc.

Stuart, FL1 decision2023–20231 recall

FDA records 1 decision for Lineage Biomedical, Inc. (Stuart, FL) in 2023: 1 510(k) clearance. All are in product code FMF (Syringe, Piston). Its devices cite 1 predicate, 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, general hospital panel, where it files most

How often FDA has decided Lineage Biomedical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2023: 1
2023high 1 (2023) · low 0 (2024)2026

2026 so far, outlined.

Recalls per year

1in 2024

2024: 1
2023high 1 (2024) · low 0 (2023)2026

Class I Class II/III not classified

FIG. 1 — Lineage Biomedical, Inc. by year, 2023–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • FMFSyringe, Piston1decision

Whose devices does it build on?

Its devices cite 1 predicate; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K231877NavaClick Injection SystemLineage Biomedical, Inc. · 20231 recall

The one decision as Lineage Biomedical, Inc. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K231877NavaClick Syringe and Needle, Model Number LIN02Jul 12, 2024Class III