Atlas FDA

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

Idaho Technology, Inc. — Predicate Candidate Screening

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

106 daysmedian FDA review time
200 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K120267FILMARRAY RP PANELIdaho Technology, Inc.2012-05-151060
K103207JBAIDS Q FEVER DETECTION KITIdaho Technology, Inc.2011-05-202000
K110764FILMARRAY RP PANELIdaho Technology, Inc.2011-04-27400
K103175FILMARRAY RESPIRATORY PANEL (RP)Idaho Technology, Inc.2011-02-171120
K072631JBAIDS PLAQUE DETECTION KIT, MODEL JRPD-ASY-0123Idaho Technology, Inc.2007-12-20930
K072547JBAIDS TULAREMIA DETECTION KIT, MODEL JRPD-ASY-0124Idaho Technology, Inc.2007-12-191000
K071188MODIFICATION TO JBAIDS ANTHRAX DETECTION SYSTEMIdaho Technology, Inc.2007-05-21210
K051713JBAIDS ANTHRAC DETECTION SYSTEMIdaho Technology, Inc.2005-11-181440

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