FDA applicant

Coapt Systems, Inc.

Palo Alto, CA17 decisions2002–20091 recall

FDA records 17 decisions for Coapt Systems, Inc. (Palo Alto, CA) from 2002 to 2009: 17 510(k) clearances. Most are in product codes HWC (Screw, Fixation, Bone) and GAM (Suture, Absorbable, Synthetic, Polyglycolic Acid). Its devices cite 29 predicates, 21 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, orthopedic panel, where it files most

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

FDA decisions per year

1in 2009

2007high 2 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

1in 2016

2007high 1 (2016) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Coapt Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Coapt Systems, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Coapt”

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

Coapt, LLC 5

Coapt Systems, Inc.

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?

What has been recalled?

Other applicant names beginning “Coapt”