FDA applicant
Implicity, Inc.
FDA records 3 decisions for Implicity, Inc. (Cambridge, MA) from 2021 to 2026: 3 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and QNL (Medium-Term Adjunctive Predictive…). Its devices cite 3 predicates, 1 of them its own earlier devices. 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 Implicity, Inc.’s devices, and how often a recall has named them.
FDA decisions per year
1in 2023
2026 so far, outlined.
Recalls per year
No recall linked to its devices since 2021.
Planning a device like Implicity, 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) Report