510(k) Report

FDA applicant

Unomedical Devices S.A DE C.V.

Reynosa, MX1 decision2012–20121 recall

FDA records 1 decision for Unomedical Devices S.A DE C.V. (Reynosa, MX) in 2012: 1 510(k) clearance. All are in product code FPA (Set, Administration, Intravascular). Its devices cite 2 predicates, 0 of them its own earlier devices. 1 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 Unomedical Devices S.A DE C.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2012

2012: 1
2012high 1 (2012) · low 0 (2013)2026

2026 so far, outlined.

Recalls per year

1in 2015

2015: 1
2012high 1 (2015) · low 0 (2012)2026

Class I Class II/III not classified

FIG. 1 — Unomedical Devices S.A DE C.V. by year, 2012–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Unomedical Devices S.A DE C.V.’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?

  • FPASet, Administration, Intravascular1decision

Whose devices does it build on?

Its devices cite 2 predicates; 0 are its own earlier devices. The firms it cites most:

What has FDA decided for it lately?

  • K120395Neria Multi Subcutaneous Infusion SetUnomedical Devices S.A DE C.V. · 20121 recall

The one decision as Unomedical Devices S.A DE C.V. →

What has been recalled?

1 recall linked to its devices; the latest:

  • K120395Sure T, contact, contact detach, neria, neria detach, neria multi and thalaset Used in…May 21, 2015Class II

Other applicant names beginning “Unomedical”

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

Unomedical A/S 13Unomedical Sdn Bhd 9Unomedical A/S Infusion Devices 1