FDA applicant
Pt. Sugih Instrumendo Abadi
FDA records 1 decision for Pt. Sugih Instrumendo Abadi (Hauppauge, NY) in 2001: 1 510(k) clearance. All are in product code DXQ (Blood Pressure Cuff). 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. Sugih Instrumendo Abadi’s devices, and how often a recall has named them.
FDA decisions per year
No FDA decision for Pt. Sugih Instrumendo Abadi since 2007.
Recalls per year
No recall linked to its devices since 2007.
Planning a device like Pt. Sugih Instrumendo Abadi’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