FDA applicant
Portex, Inc.
FDA records 27 decisions for Portex, Inc. (Mchenry, IL) from 1977 to 2004: 27 510(k) clearances. Most are in product codes BTO (Tube, Tracheostomy (W/Wo Connector)) and BTM (Ventilator, Emergency, Manual (Resuscitator)). Its devices cite 30 predicates, 1 of them its own earlier devices. 21 recalls are linked to its devices.
FDA’s records also spell it “Portex , Ltd.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Portex, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Portex, Inc. since 2007.
Recalls per year
1in 2019
Class I Class II/III not classified
Planning a device like Portex, 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