FDA applicant

Penlon, Inc.

Mchenry, IL22 decisions1980–20062 recalls

FDA records 22 decisions for Penlon, Inc. (Mchenry, IL) from 1980 to 2006: 22 510(k) clearances. Most are in product codes CAD (Vaporizer, Anesthesia, Non-Heated) and CAP (Monitor, Airway Pressure (Includes Gauge…). Its devices cite 10 predicates, 4 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Penlon , Ltd.”, “Penlon Limited”.

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 Penlon, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Penlon, Inc. since 2007.

Recalls per year

1in 2013

2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

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

Planning a device like Penlon, Inc.’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

Penlon, 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?