510(k) Report

FDA applicant

Crosstex/Spsmedical, A Division of Cantel Medical

Rush, NY2 decisions2017–20180 recalls

FDA records 2 decisions for Crosstex/Spsmedical, A Division of Cantel Medical (Rush, NY) from 2017 to 2018: 2 510(k) clearances. All are in product code FRC (Indicator, Biological Sterilization Process). Its devices cite 3 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 hospital panel, where it files most

How often FDA has decided Crosstex/Spsmedical, A Division of Cantel Medical’s devices, and how often a recall has named them.

FDA decisions per year

1in 2018

2017: 12018: 1
2017high 1 (2017) · low 0 (2019)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Crosstex/Spsmedical, A Division of Cantel Medical by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Crosstex/Spsmedical”

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