Atlas FDA

Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

Inverness Medical Innovations, Inc. · Predicate Candidate Screening

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

49 daysmedian FDA review time
207 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K071265SMARTCHECK INR SYSTEMInverness Medical Innovations, Inc.2007-11-302070
K071587ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST) ASSAYInverness Medical Innovations, Inc.2007-07-30490
K060133ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB) ASSAY VERIFICATIOInverness Medical Innovations, Inc.2006-02-16290
K053196ISCHEMIA ALBUMIN COBALT BINDING TEST (ACB TEST)Inverness Medical Innovations, Inc.2005-12-16300
K011479ONE TOUCH FASTTAKE COMPACT BLOOD GLUCOSE MONITORING SYSTEM, Inverness Medical Innovations, Inc.2001-11-302000
K011616INDUO BLOOD GLUCOSE METERInverness Medical Innovations, Inc.2001-06-21270

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