510(k) Report

FDA applicant

Unoplast A/S

Denmark, DK7 decisions1980–199015 recalls

FDA records 7 decisions for Unoplast A/S (Denmark, DK) from 1980 to 1990: 7 510(k) clearances. Most are in product codes KOD (Catheter, Urological) and BZB (Catheter, Nasal, Oxygen). 15 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, gastroenterology and urology panel, where it files most

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

FDA decisions per year

No FDA decision for Unoplast A/S since 2007.

Recalls per year

2in 2019

2011: 132019: 2
2007high 13 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Unoplast 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?

  • KODCatheter, Urological1decision
  • BZBCatheter, Nasal, Oxygen1decision
  • BSYCatheters, Suction, Tracheobronchial1decision
  • FPDTube, Feeding1decision
  • GAOSuture, Nonabsorbable1decision
  • EXRUrinometer, Mechanical1decision

Also: KGX (1).

Who builds on its devices?

Later devices cite its devices 2 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.

  • K896729Nelaton-, Female - or Tiemann CatheterUnoplast A/S · 19902cite it

What has FDA decided for it lately?

  • K896734Feeding TubeUnoplast A/S · 19901 recall
  • K896729Nelaton-, Female - or Tiemann CatheterUnoplast A/S · 199014 recalls
  • K896732Unometer 500Unoplast A/S · 1990
  • K896731Oxygen CathetersUnoplast A/S · 1990
  • K896730Suction Catheter Straight/CoudeUnoplast A/S · 1990
  • K896733VacconUnoplast A/S · 1990
  • K802248Disarp OriginalUnoplast A/S · 1980

All 7 as Unoplast A/S →

What has been recalled?

15 recalls linked to its devices; the latest:

  • K896729Nelaton Urinary Catheter, disposable, sterile, 100 eaches per sales unit. Labeled as…Jan 9, 2019Class II
  • K896734Feeding Tube Metric, disposable, sterile, 100 eaches per sales unit. Labeled as: xray…Jan 9, 2019Class II
  • K896729RUSCH, GB: Female Catheter, All Purpose PVC, 12 Fr. 18 cm, Distributed by Teleflex…Jun 30, 2011
  • K896729RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 20 Fr. 40 cm, Distributed by…Jun 30, 2011
  • K896729RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 40 Fr. 40 cm, Distributed by…Jun 30, 2011
  • K896729RUSCH, GB: Robinson/Nelaton Catheter, All Purpose PVC 18 Fr. 40 cm, Distributed by…Jun 30, 2011