FDA applicant
Northgate Technologies, Inc.
FDA records 55 decisions for Northgate Technologies, Inc. (Arlington Heights, IL) from 1991 to 2021: 55 510(k) clearances. Most are in product codes HIF (Insufflator, Laparoscopic) and FFK (Lithotriptor, Electro-Hydraulic). Its devices cite 5 predicates, 3 of them its own earlier devices. 9 recalls are linked to its devices.
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly
How often FDA has decided Northgate Technologies, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
2in 2021
2026 so far, outlined.
Recalls per year
1in 2022
Class I Class II/III not classified
Planning a device like Northgate Technologies, 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) ReportOther applicant names beginning “Northgate”
FDA records each applicant name separately; these may or may not be the same firm.