Atlas FDA

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

Honeywell Hommed, LLC · Predicate Candidate Screening

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

52 daysmedian FDA review time
158 days90th percentile
7clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K153719LifeStream Management System, LifeStream Management Suite, LHoneywell Hommed, LLC2016-06-031580
K112858GENESIS TOUCH SYSTEMHoneywell Hommed, LLC2012-01-241160
K101242GENESIS DM MODEL: 6053000A1Honeywell Hommed, LLC2010-06-11390
K072272HONEYWELL HOMMED CENTRAL STATION 4.0Honeywell Hommed, LLC2007-09-07230
K061088SENTRY OTC MONITORHoneywell Hommed, LLC2006-06-09520
K061087GENESIS OTC MONITORHoneywell Hommed, LLC2006-06-09520
K053453HOMMED CENTRAL STATION, VERSION 3.5Honeywell Hommed, LLC2006-05-051440

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