FDA applicant
Pneupac, Ltd.
FDA records 20 decisions for Pneupac, Ltd. (Mchenry, IL) from 1980 to 2004: 20 510(k) clearances. Most are in product codes BTL (Ventilator, Emergency, Powered (Resuscitator)) and CBK (Ventilator, Continuous, Facility Use). Its devices cite 3 predicates, 2 of them its own earlier devices. No recall is linked to its devices.
FDA’s records also spell it “Pneupac, Inc.”.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pneupac, Ltd.’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pneupac, Ltd. since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pneupac, Ltd.’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