510(k) Report

FDA applicant

Wireless Monitors, Inc.

Southampton, NY1 decision1986–19860 recalls

FDA records 1 decision for Wireless Monitors, Inc. (Southampton, NY) in 1986: 1 510(k) clearance. All are in product code BZQ (Monitor, Breathing Frequency). 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, anesthesiology panel, where it files most

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

FDA decisions per year

No FDA decision for Wireless Monitors, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • BZQMonitor, Breathing Frequency1decision

What has FDA decided for it lately?

  • K862962Apnet Respiration MonitorWireless Monitors, Inc. · 1986

The one decision as Wireless Monitors, Inc. →

Other applicant names beginning “Wireless”

FDA records each applicant name separately; these may or may not be the same firm.

Wireless 2000 RF & Uwb Technologies, Ltd. 1Wireless Medcare, LLC 1