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

Tyson Bioresearch, Inc. · Predicate Candidate Screening

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

208 daysmedian FDA review time
323 days90th percentile
13clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182046Tyson Bio HS100 Blood Glucose Monitoring System, Tyson Bio HTyson Bioresearch, Inc.2018-11-301220
K182047Tyson Bio HT100-A Blood Glucose Monitoring System; Tyson BioTyson Bioresearch, Inc.2018-11-291210
K170079Tyson Bio HT100 Blood Glucose Monitoring System, Tyson Bio HTyson Bioresearch, Inc.2017-10-062690
K123087TYSONBIO AC500, AC800 BLOOD GLUCOSE MONITORING SYSTEM, TYSONTyson Bioresearch, Inc.2013-06-182600
K112916TYSONBIO MD100 BLOOD GLUCSE MONITORING ,TYSONBIO MD100 PRO BTyson Bioresearch, Inc.2012-08-213230
K101543TYSONBIO BLOOD GLUCOSE MONITORING SYSTEM, MODELS AC100 AND ATyson Bioresearch, Inc.2011-08-304530
K090629EASY STEP AND DIACHEX+ PRO BLOOD GLUCOSE MONITORING SYSTEMSTyson Bioresearch, Inc.2009-06-04870
K081726TYSONBIO LINK HEALTH MANAGEMENT SYSTEMTyson Bioresearch, Inc.2008-08-26690
K072854DIACHEX BASIC BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX SUPERTyson Bioresearch, Inc.2008-06-302690
K073492DIACHEX+DETERMINE BLOOD GLUCOSE MONITORING SYSTEM, DIACHEX-ITyson Bioresearch, Inc.2008-04-081180
K072441EZ SCAN PLUS BLOOD GLUCOSE MONITORING SYSTEMTyson Bioresearch, Inc.2008-03-252080
K062829DIACHEX BLOOD GLUCOSE MONITORING SYSTEMTyson Bioresearch, Inc.2006-10-10200
K052818EZ SMART-168 GLUCOSE MONITORING SYSTEMTyson Bioresearch, Inc.2006-06-162550

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