FDA applicant

Cone Bioproducts

Seguin, TX3 decisions2005–20120 recalls

FDA records 3 decisions for Cone Bioproducts (Seguin, TX) from 2005 to 2012: 3 510(k) clearances. Most are in product codes JJX (Single (Specified) Analyte Controls (Assayed…) and JJY (Multi-Analyte Controls, All Kinds (Assayed)). Its devices cite 3 predicates, 1 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, clinical chemistry panel, where it files most

How often FDA has decided Cone Bioproducts’s devices, and how often a recall has named them.

FDA decisions per year

2in 2012

2007high 2 (2012) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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

See the 510(k) Report

Other applicant names beginning “Cone”

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

Cone Instruments, Inc. 4

Cone Bioproducts

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 “Cone”