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

Ameritek, Inc. — Predicate Candidate Screening

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

68 daysmedian FDA review time
201 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K001215DBEST HCG 2 IU/ML TEST KITAmeritek, Inc.2000-06-22690
K990873DBEST URINARY TRACT INFECTION TEST KIT FOR HOME-USEAmeritek, Inc.1999-09-011690
K990681DBSET MULTIDRUG SCREEN TEST KITAmeritek, Inc.1999-07-151350
K984269DBEST OCCULT BLOOD TEST KITAmeritek, Inc.1999-05-112010
K983191DBEST COCAINE TEST KITAmeritek, Inc.1998-11-18680
K983190DBEST OPIATES TEST KITAmeritek, Inc.1998-11-18680
K983189DBEST METHAMPHETAMINES TEST KITAmeritek, Inc.1998-11-18680
K983188DBEST TETRAHYDROCANNABINOL TEST KITAmeritek, Inc.1998-11-18680
K981504DBEST AMPHETAMINES TEST KITAmeritek, Inc.1998-08-061010
K974508DBEST ONE-STEP OVULATION TESTAmeritek, Inc.1998-02-02630
K973957DBEST ONE-STEP HCG SERUM/URINE TESTAmeritek, Inc.1997-12-17620
K973142DBEST REAGENT STRIP FOR URINALYSISAmeritek, Inc.1997-10-20600
K953606BEST PREGNANCY TESTAmeritek, Inc.1996-03-222330
K863775RK VACUUM FIXATION RING SYSTEMAmeritek, Inc.1986-10-20240
K863235SURGICAL IOP MONITORAmeritek, Inc.1986-09-25350
K861013ELECTRICALLY CONTROLLED I.V. POLE (OPTHALMIC)Ameritek, Inc.1986-03-31130
K860960RARE EARTH INTRA-OCULAR MAGNETAmeritek, Inc.1986-03-31180

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