510(k) Report

FDA applicant

Non-Invasive Monitoring Systems, Inc.

Arlington, VA6 decisions1989–20010 recalls

FDA records 6 decisions for Non-Invasive Monitoring Systems, Inc. (Arlington, VA) from 1989 to 2001: 6 510(k) clearances. Most are in product codes DQK (Computer, Diagnostic, Programmable) and BZQ (Monitor, Breathing Frequency). Its devices cite 1 predicate, 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 Non-Invasive Monitoring Systems, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Non-Invasive Monitoring Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Non-Invasive Monitoring Systems, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Non-Invasive Monitoring Systems, 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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