510(k) Report

FDA applicant

Integrated Sensing Systems, Inc.

Ypsilanti, MI1 decision2006–20060 recalls

FDA records 1 decision for Integrated Sensing Systems, Inc. (Ypsilanti, MI) in 2006: 1 510(k) clearance. All are in product code FLN (Monitor, Electric For Gravity Flow Infusion…). 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, general hospital panel, where it files most

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

FDA decisions per year

No FDA decision for Integrated Sensing Systems, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Integrated Sensing 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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