FDA applicant
Pt&E
FDA records 1 decision for Pt&E (Mchenry, IL) in 1981: 1 510(k) clearance. All are in product code LHB (Timer, Apgar). No recall is linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Pt&E’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pt&E since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pt&E’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