Atlas FDA

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

Hommed, LLC · Predicate Candidate Screening

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

124 daysmedian FDA review time
260 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K040799HOMMED GENESIS PATIENT MONITOR SYSTEM WITH OPTIONSHommed, LLC2004-08-181420
K040651HOMMED SENTRY IIIB-F PATIENT MONITOR SYSTEMHommed, LLC2004-08-101520
K040032CENTRAL STATION, VERSION 3.3HHommed, LLC2004-02-27500
K020184HOMMED CENTRAL STATIONHommed, LLC2002-04-22940
K014025HOMMED SENTRY III PATIENT MONITOR SYSTEM WITH CARD READERHommed, LLC2002-04-091240
K003180HOMMED OBSERVER, MODEL IHommed, LLC2001-06-282600
K004044HOMMED SENTRY III PATIENT MONITOR SYSTEMHommed, LLC2001-03-02630
K993938THE HOMMED SENTRY, MODEL 1 SENTRYHommed, LLC2000-03-151170

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