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

Wyntek Diagnostics, Inc. — Predicate Candidate Screening

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

48 daysmedian FDA review time
162 days90th percentile
12clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K992658OSOM ULTRA STREP A TEST, MODEL 147Wyntek Diagnostics, Inc.2000-01-181620
K990578OSOM CARD II HCG-URINE TEST, MODEL 102Wyntek Diagnostics, Inc.1999-03-09140
K990576OSOM CARD PREGNANCY TEST, MODEL 103Wyntek Diagnostics, Inc.1999-03-09140
K974159OSOM HCG-URINE TEST MODEL 101Wyntek Diagnostics, Inc.1997-12-24710
K973879OSOM CARD HCG-URINE TESTWyntek Diagnostics, Inc.1997-11-04550
K972231OSOM MONO TEST 143Wyntek Diagnostics, Inc.1997-08-26710
K965227OSOM CLASSIC HCG-URINE TEST (115)Wyntek Diagnostics, Inc.1997-02-04360
K965184PERFECTA PREGNANCY TESTWyntek Diagnostics, Inc.1997-02-04420
K961423OSOM STREP A TESTWyntek Diagnostics, Inc.1996-10-111820
K955141OSOM HCG COMBO TESTWyntek Diagnostics, Inc.1995-12-06230
K954178OSOM PREGNANCY TESTWyntek Diagnostics, Inc.1995-10-23480
K953383WYNTEK OSOM HCG-URINE TESTWyntek Diagnostics, Inc.1995-08-29410

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