FDA applicant

Concord/Portex

Keene, NH23 decisions1989–19934 recalls

FDA records 23 decisions for Concord/Portex (Keene, NH) from 1989 to 1993: 23 510(k) clearances. Most are in product codes BTO (Tube, Tracheostomy (W/Wo Connector)) and FMI (Needle, Hypodermic, Single Lumen). Its devices cite 1 predicate, 1 of them its own earlier devices. 4 recalls are 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 Concord/Portex’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Concord/Portex since 2007.

Recalls per year

1in 2017

2007high 1 (2017) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Concord/Portex’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 “Concord/Portex”

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

Concord Laboratories, Inc. 42 Concord Imaging, Ltd. 1 Concord Medical Products 1 Concord Protex 1

Concord/Portex

Which product codes does it file in?

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 “Concord/Portex”