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

Home Diagnostics, Inc. — Predicate Candidate Screening

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

112 daysmedian FDA review time
251 days90th percentile
22clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K090495TRUEBALANCE BLOOD GLUCOSE SYSTEMHome Diagnostics, Inc.2009-03-27301
K080641TRUERESULT BLOOD GLUCOSE SYSTEM E4H01-81Home Diagnostics, Inc.2008-08-191660
K080710TRUE2GO BLOOD GLUCOSE SYSTEM, MODEL F4H01-81Home Diagnostics, Inc.2008-08-131530
K070593TRACKRECORD DATA MANAGEMENT SOFTWAREHome Diagnostics, Inc.2007-05-07660
K060793ELEMENT BLOOD GLUCOSE TEST SYSTEMHome Diagnostics, Inc.2006-07-251240
K051147SIDEKICK BLOOD GLUCOSE TEST SYSTEMHome Diagnostics, Inc.2005-07-12690
K042080TRACKEASE SMART SYSTEM BLOOD GLUCOSE SYSTEMHome Diagnostics, Inc.2004-08-19160
K040670MODIFICATION TO TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, Home Diagnostics, Inc.2004-03-25100
K032657TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER, BLOOD GLUCOSE TEHome Diagnostics, Inc.2004-03-242092
K030703TRUETRACK SMART SYSTEM BLOOD GLUCOSE METER AND TRUE TRACK SMHome Diagnostics, Inc.2003-07-111271
K010403PRESTIGE IQ BLOOD GLUCOSE TEST SYSTEM, MODEL 507400, 537600,Home Diagnostics, Inc.2001-03-26420
K992988PRESTIGE LX BLOOD GLUCOSE TEST SYSTEMHome Diagnostics, Inc.1999-09-24210
K960855PRESTIGE BLOOD GLUCOSE MONITORING SYSTEM,METER,TEST STRIPS &Home Diagnostics, Inc.1996-11-072510
K922136ULTRA+ BLOOD GLUCOSE MONITORING TEST STRIPHome Diagnostics, Inc.1993-08-104750
K922137DIASCAN BLOOD GLUCOSE MONITORING TEST STRIPHome Diagnostics, Inc.1993-08-104750
K915770ULTRA+ BLOOD GLUCOSE TEST STRIPHome Diagnostics, Inc.1992-04-141120
K915772DIASCAN BLOOD GLUCOSE MONITORING TEST STRIPHome Diagnostics, Inc.1992-04-141120
K912440ULTRA BLOOD GLUCOSE MONITORING SYSTEMHome Diagnostics, Inc.1991-07-17440
K872505DIASCAN* BLOOD GLUCOSE SELF-MONITORING TEST STRIPSHome Diagnostics, Inc.1987-10-201180
K861265DIALET LANCING DEVICEHome Diagnostics, Inc.1986-04-30260
K853553DIASCAN CONTROLHome Diagnostics, Inc.1985-09-16210
K851618DIASCAN BLOOD GLUCOSE SELF-MONITOR TEST STRIPSHome Diagnostics, Inc.1985-08-061100

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