510(k) Report

FDA applicant

Peace Medical, Inc.

Orange, NJ3 decisions1985–19910 recalls

FDA records 3 decisions for Peace Medical, Inc. (Orange, NJ) from 1985 to 1991: 3 510(k) clearances. Most are in product codes BSK (Cuff, Tracheal Tube, Inflatable) and CBN (Apparatus, Gas-Scavenging). 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 Peace Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Peace Medical, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Peace Medical, 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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Which product codes does it file in?

  • BSKCuff, Tracheal Tube, Inflatable1decision
  • CBNApparatus, Gas-Scavenging1decision
  • JAXPneumotachometer1decision

What has FDA decided for it lately?

  • K912352Peace Model 100 Cuff MonitorPeace Medical, Inc. · 1991
  • K902161Demistifier Isolation ChamberPeace Medical, Inc. · 1990
  • K853085Pax MeterPeace Medical, Inc. · 1985

All 3 as Peace Medical, Inc. →