510(k) Report

FDA applicant

Unomedical A/S

Roskilde, DK13 decisions2003–202114 recalls

FDA records 13 decisions for Unomedical A/S (Roskilde, DK) from 2003 to 2021: 13 510(k) clearances. Most are in product codes FPA (Set, Administration, Intravascular) and FOZ (Catheter, Intravascular, Therapeutic…). Since 2016 its 510(k)s took a median of 142 days from receipt to decision, against 186 for FDA’s reviews in the same codes and years. Its devices cite 29 predicates, 11 of them its own earlier devices. 14 recalls are linked to its devices, 3 Class I.

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 A/S’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2007: 12012: 12013: 12016: 12017: 12018: 12019: 12021: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

2in 2024

2011: 12014: 32017: 42022: 12023: 3, 3 Class I2024: 2
2007high 4 (2017) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Unomedical A/S 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?

  • FPASet, Administration, Intravascular12decisions
  • FOZCatheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days1decision

How long do its 510(k) reviews take?

Since 2016, its 5 510(k)s took a median of 142 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 186 days; 4 of its 5 were faster than that.

Whose devices does it build on?

Its devices cite 29 predicates; 11 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 14 times; 11 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.

  • K032854Unomedical Monica Infusion SetUnomedical A/S · 20038cite it
  • K173879MiniMed Mio Advance infusion setUnomedical A/S · 20182cite it
  • K061374Intuition Infusion SetsUnomedical A/S · 20061cites it
  • K051264Comfort and Inset Subcutaneous Infusion Sets for Use with Abbott Infusion PumpsUnomedical A/S · 20051cites it
  • K041545Contact DetachUnomedical A/S · 20041cites it
  • K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S · 20161cites it

What has FDA decided for it lately?

  • K210544Medtronic Extended infusion setUnomedical A/S · 2021
  • K192647neria guard Infusion SetUnomedical A/S · 2019
  • K173879MiniMed Mio Advance infusion setUnomedical A/S · 2018
  • K162812Unomedical Comfort Subcutaneous Infusion Set, Unomedical Comfort Short Subcutaneous Infusion Set, Unomedical…Unomedical A/S · 20173 Class I recalls
  • K160648MiniMed Quick-Set® MiniMed Sure-T® MiniMed Silhouette® MiniMed Mio®Unomedical A/S · 20164 recalls
  • K132142Neria Soft 90 Infusion SetUnomedical A/S · 2013
  • K120337I-Port Advance Injection PortUnomedical A/S · 2012
  • K070430Paradigm Quick-Set II and Quick-Set II Subcutaneous Infusion SetsUnomedical A/S · 2007

All 13 as Unomedical A/S →

What has been recalled?

14 recalls linked to its devices; the latest:

  • K162812VariSoft Infusion Set, Single Use.Jul 23, 2024Class II
  • K162812Neria Soft Infusion Set, Product Code 507302, intravascular administration setMar 5, 2024Class II
  • K162812VariSoft infusion set, Model Number 1002830Oct 11, 2023Class I
  • K162812VariSoft infusion set, Model Number 1002827Oct 11, 2023Class I
  • K162812VariSoft infusion set, Model Number 1002828Oct 11, 2023Class I
  • K032854Autosoft 90, model numbers 1000282, 1002817, 1002818, 1002819, 1002820, 1002821…Jul 21, 2022Class II

Other applicant names beginning “Unomedical”

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

Unomedical Sdn Bhd 9Unomedical Devices S.A DE C.V. 1Unomedical A/S Infusion Devices 1