510(k) Report

FDA applicant

Implicity, Inc.

Cambridge, MA3 decisions2021–20260 recalls

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, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Implicity, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2023

2021: 12023: 12026 (partial year): 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Implicity, Inc. by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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.

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