510(k) Report

FDA applicant

Bioteque Corp.

Flaggstaff, AZ14 decisions1992–20250 recalls

FDA records 14 decisions for Bioteque Corp. (Flaggstaff, AZ) from 1992 to 2025: 14 510(k) clearances. Most are in product codes FGE (Stents, Drains And Dilators For The Biliary…) and FPA (Set, Administration, Intravascular). Since 2016 its 510(k)s took a median of 346 days from receipt to decision, against 111 for FDA’s reviews in the same codes and years. Its devices cite 16 predicates, 4 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Bioteque Corporation”.

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 Bioteque Corp.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2011: 12016: 12020: 12022: 12025: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Bioteque Corp. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Bioteque Corp.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Which product codes does it file in?

  • FGEStents, Drains And Dilators For The Biliary Ducts4decisions
  • FPASet, Administration, Intravascular2decisions
  • FJKSet, Tubing, Blood, With And Without Anti-Regurgitation Valve2decisions
  • FADStent, Ureteral1decision
  • DREDilator, Vessel, For Percutaneous Catheterization1decision
  • FIENeedle, Fistula1decision

Also: FOZ (1), HHK (1), DQO (1).

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 346 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 111 days; 0 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 16 predicates; 4 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 9 times; 4 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.

  • K200103BIOTEQ Drainage Catheter Set (One Step Type)Bioteque Corporation · 20203cite it
  • K210419BIOTEQ Drainage Catheter BT-PDS-seriesBioteque Corporation · 20222cite it
  • K033210Bioteq Double Pigtail Ureteral Stent SetBioteque Corp. · 20042cite it
  • K033862Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String LockBioteque Corp. · 20051cites it
  • K915491CurelleBioteque Corp. · 19921cites it

What has FDA decided for it lately?

  • K251019BIOTEQ Drainage Catheter Set: BT-PD1-SERIES-G and BT-PDS-SERIES-GBioteque Corporation · 2025
  • K210419BIOTEQ Drainage Catheter BT-PDS-seriesBioteque Corporation · 2022
  • K200103BIOTEQ Drainage Catheter Set (One Step Type)Bioteque Corporation · 2020
  • K150932Sheath IntroducerBioteque Corp. · 2016
  • K102633Bioteq Angiographic CatheterBioteque Corp. · 2011
  • K033862Bioteq Pigtail Drainage Catheter Set (One Step Type) with or Without Safety String LockBioteque Corp. · 2005
  • K033210Bioteq Double Pigtail Ureteral Stent SetBioteque Corp. · 2004
  • K032292Bioteque a.V. Fistula Needle Set with Safety FlexBioteque Corp. · 2004

All 11 as Bioteque Corp. →All 3 as Bioteque Corporation →

Other applicant names beginning “Bioteque”

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

Bioteque America, Inc. 10