FDA applicant
Painchek Limited (Ltd.)
FDA records 1 decision for Painchek Limited (Ltd.) (Sydney, AU) in 2025: 1 De Novo grant. All are in product code SGB (Pain Assessment Software In Non-Communicative…). 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 Painchek Limited (Ltd.)’s devices, and how often a recall has named them.
FDA decisions per year
1in 2025
2025high 1 (2025)2026
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2025.
Planning a device like Painchek Limited (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