510(k) Report

FDA applicant

Jd Monitoring C/O Mackler, Cooper and Gibbs

Washington, DC1 decision1987–19874 recalls

FDA records 1 decision for Jd Monitoring C/O Mackler, Cooper and Gibbs (Washington, DC) in 1987: 1 510(k) clearance. All are in product code KMI (Monitor, Bed Patient). 4 recalls are 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 Jd Monitoring C/O Mackler, Cooper and Gibbs’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Jd Monitoring C/O Mackler, Cooper and Gibbs since 2007.

Recalls per year

4in 2010

2010: 4
2007high 4 (2010) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Jd Monitoring C/O Mackler, Cooper and Gibbs 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?

  • KMIMonitor, Bed Patient1decision

What has FDA decided for it lately?

  • K873806JDM SP2 SensorJd Monitoring C/O Mackler, Cooper and Gibbs · 19874 recalls

The one decision as Jd Monitoring C/O Mackler, Cooper and Gibbs →

What has been recalled?

4 recalls linked to its devices; the latest:

  • K873806Tabs Professional Monitor Without Wall Bracket, Model 25023. Stanley Senior…Mar 26, 2010
  • K873806Tabs Professional Monitor, includes one wall bracket, Model 25022. Stanley Senior…Mar 26, 2010
  • K873806Tabs Professional Monitor with Wire Bracket and Push Button Reset, Model 25223, Stanley…Mar 26, 2010
  • K873806Tabs Professional Monitor Without Pull Cord or wall bracket, Model 25025, Stanley Senior…Mar 26, 2010