510(k) Report

FDA applicant

Tidi Products,Llc

Neenah, WI3 decisions2010–20140 recalls

FDA records 3 decisions for Tidi Products,Llc (Neenah, WI) from 2010 to 2014: 3 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and PEM (Dental Barriers And Sleeves). Its devices cite 4 predicates, 1 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 Tidi Products,Llc’s devices, and how often a recall has named them.

FDA decisions per year

1in 2014

2010: 22014: 1
2010high 2 (2010) · low 0 (2011)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Tidi Products,Llc by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Tidi Products,Llc’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?

  • FXXMask, Surgical2decisions
  • PEMDental Barriers And Sleeves1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 6 times; 1 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.

  • K132953TidisheildTidi Products,Llc · 20143cite it
  • K092580Tidi FacemaskTidi Products,Llc · 20103cite it

What has FDA decided for it lately?

  • K132953TidisheildTidi Products,Llc · 2014
  • K100800Tidi FacemaskTidi Products,Llc · 2010
  • K092580Tidi FacemaskTidi Products,Llc · 2010

All 3 as Tidi Products,Llc →