510(k) Report

FDA applicant

Pt Products, LLC

Farmington Hills, MI1 decision2008–20082 recalls

FDA records 1 decision for Pt Products, LLC (Farmington Hills, MI) in 2008: 1 510(k) clearance. All are in product code ITH (Equipment, Traction, Powered). Its devices cite 3 predicates, 0 of them its own earlier devices. 2 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, physical medicine panel, where it files most

How often FDA has decided Pt Products, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2008

2008: 1
2008high 1 (2008) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

2in 2008

2008: 2
2008high 2 (2008) · low 0 (2009)2026

Class I Class II/III not classified

FIG. 1 — Pt Products, LLC by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • ITHEquipment, Traction, Powered1decision

Whose devices does it build on?

Its devices cite 3 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K073542Cycletrac CT-5000Pt Products, LLC · 20082 recalls

The one decision as Pt Products, LLC →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K073542GE OEC 9900 Elite ESP fluoroscopic x-ray system. GE Healthcare, Surgery, Salt Lake City…Aug 29, 2008
  • K073542GE OEC 9900 Elite GSP fluoroscopic x-ray system GE Healthcare, Surgery, Salt Lake City…Aug 29, 2008