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Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Bioteque America, Inc. — Predicate Candidate Screening

10 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

227 daysmedian FDA review time
1365 days90th percentile
10clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K041094HSG CATHETER SETBioteque America, Inc.2004-06-17510
K020628CURELLE, PREFERRED CURELLE, CUTEQ 2.5Bioteque America, Inc.2002-05-24870
K013289BIOTEQUE VAGINAL PESSARIESBioteque America, Inc.2001-12-27860
K003380BIOTEQUE VAGINAL DILATORBioteque America, Inc.2001-01-29900
K920633PESSARY FLEXIBLE SILICONE NICHOLSBioteque America, Inc.1995-11-0813650
K920747PESSARY FLEXIBLE SILICONE DONUT RINGBioteque America, Inc.1994-08-299220
K933628CYTOLOGY BRUSHBioteque America, Inc.1994-03-112270
K933521SPECULUMBioteque America, Inc.1994-03-072300
K920187FLEXIBLE SILICONE GELIHORNBioteque America, Inc.1992-10-232830
K920177VERSA-VIALBioteque America, Inc.1992-07-131810

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