510(k) Report

FDA applicant

Talley Medical

Lansing, MI3 decisions2008–20090 recalls

FDA records 3 decisions for Talley Medical (Lansing, MI) from 2008 to 2009: 3 510(k) clearances. Most are in product codes OMP (Negative Pressure Wound Therapy Powered…) and DWJ (System, Thermal Regulating). Its devices cite 9 predicates, 0 of them its own earlier devices. 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 and plastic surgery panel, where it files most

How often FDA has decided Talley Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2009

2008: 22009: 1
2008high 2 (2008) · low 0 (2010)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

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

Planning a device like Talley Medical’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • OMPNegative Pressure Wound Therapy Powered Suction Pump2decisions
  • DWJSystem, Thermal Regulating1decision

Whose devices does it build on?

Its devices cite 9 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K080897Venturi Negative Pressure Wound Therapy SystemTalley Medical · 20083cite it
  • K090258Venturi NPWT V. II Advanced Vacuum SystemTalley Medical · 20091cites it

What has FDA decided for it lately?

  • K090258Venturi NPWT V. II Advanced Vacuum SystemTalley Medical · 2009
  • K080897Venturi Negative Pressure Wound Therapy SystemTalley Medical · 2008
  • K080763Tablegard Pressure Relieving Patient Warming Mattress, Model: TG 700 HTTalley Medical · 2008

All 3 as Talley Medical →

Other applicant names beginning “Talley”

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

Talley Group, Ltd. 6