FDA applicant

Cogent Therapeutics, LLC

Pleasanton, CA1 decision2012–20120 recalls

FDA records 1 decision for Cogent Therapeutics, LLC (Pleasanton, CA) in 2012: 1 510(k) clearance. All are in product code LYA (Splint, Intranasal Septal). Its devices cite 5 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, ear, nose and throat panel, where it files most

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

FDA decisions per year

1in 2012

2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2012.

FIG. 1 — Cogent Therapeutics, LLC by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Cogent”

FDA records each applicant name separately; these may or may not be the same firm.

Cogent Diagnotics, Ltd. 31 Cogent Light Technologies, Inc. 5 Cogent Spine, LLC 3 Cogent 1

Cogent Therapeutics, LLC

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Cogent”