Atlas FDA

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

Incontrol Medical, LLC · Predicate Candidate Screening

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

72 daysmedian FDA review time
397 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K182022ApexMVIncontrol Medical, LLC2019-03-152310
K150183ApexMIncontrol Medical, LLC2015-04-09720
K150180InToneIncontrol Medical, LLC2015-03-16480
K141158APEXIncontrol Medical, LLC2014-11-262050
K134020INTONEMVIncontrol Medical, LLC2014-02-25570
K133826INTONEMVIncontrol Medical, LLC2014-01-06200
K110179INCONTROLIncontrol Medical, LLC2012-02-223970

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