510(k) Report

FDA applicant

Crosstex Intl.

Great Neck, NY2 decisions1999–20022 recalls

FDA records 2 decisions for Crosstex Intl. (Great Neck, NY) from 1999 to 2002: 2 510(k) clearances. Most are in product codes FXX (Mask, Surgical) and EFQ (Gauze/Sponge, Internal). Its devices cite 5 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, general and plastic surgery panel, where it files most

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

FDA decisions per year

No FDA decision for Crosstex Intl. since 2007.

Recalls per year

2in 2022

2022: 2
2007high 2 (2022) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Crosstex Intl. 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?

  • FXXMask, Surgical1decision
  • EFQGauze/Sponge, Internal1decision

Whose devices does it build on?

Its devices cite 5 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 5 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.

  • K012602Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White…Crosstex Intl. · 20025cite it

What has FDA decided for it lately?

  • K012602Crosstex Isolite Earloop Face Masks-Blue, Pink, Crosstex Isofluid Earloop Face Masks-Blue, Pink, White…Crosstex Intl. · 2002
  • K984187Crosstex Non-Woven SpongesCrosstex Intl. · 19992 recalls

All 2 as Crosstex Intl. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K984187Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 2,000 per case 10 sleeves of 200 4 in x 4…Mar 22, 2022Class II
  • K984187Ultra Pure Non-Woven Sponges Non-Sterile 4-Ply 5,000 per case 25 sleeves of 200 2 in x 2…Mar 22, 2022Class II

Other applicant names beginning “Crosstex”

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

Crosstex International 6Crosstex/Spsmedical, A Division of Cantel Medical 2Crosstex International, Inc. (A Cantel Medical Company) 1Crosstex 1