Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Bioteque Corp. — Predicate Candidate Screening
11 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
246 daysmedian FDA review time
454 days90th percentile
11clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150932 | Sheath Introducer | Bioteque Corp. | 2016-07-22 | 473 | 0 |
| K102633 | BIOTEQ ANGIOGRAPHIC CATHETER | Bioteque Corp. | 2011-09-09 | 361 | 0 |
| K033862 | BIOTEQ PIGTAIL DRAINAGE CATHETER SET (ONE STEP TYPE) WITH OR | Bioteque Corp. | 2005-02-14 | 430 | 0 |
| K033210 | BIOTEQ DOUBLE PIGTAIL URETERAL STENT SET | Bioteque Corp. | 2004-12-30 | 454 | 0 |
| K032292 | BIOTEQUE A.V. FISTULA NEEDLE SET WITH SAFETY FLEX | Bioteque Corp. | 2004-03-22 | 242 | 0 |
| K013634 | BIOTEQUE 3 IN 1 HEMODIALYSIS BLOOD TUBING PACK | Bioteque Corp. | 2002-07-09 | 246 | 0 |
| K012526 | BIOTEQUE SCALP VEIN SET | Bioteque Corp. | 2001-09-14 | 39 | 0 |
| K002449 | BIOTEQ I.V. (INTRAVENOUS) SET | Bioteque Corp. | 2000-12-22 | 135 | 0 |
| K992930 | BIOTEQUE HEMODIALYSIS BLOOD TUBING SET | Bioteque Corp. | 2000-02-09 | 162 | 0 |
| K993118 | BIOTEQUE A.V. FISTULA NEEDLE SET | Bioteque Corp. | 1999-12-17 | 88 | 0 |
| K915491 | CURELLE | Bioteque Corp. | 1992-11-04 | 334 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda