Atlas FDA

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

Allmed Systems, Inc. · Predicate Candidate Screening

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

80 daysmedian FDA review time
687 days90th percentile
8clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K132975SPHINX JRAllmed Systems, Inc.2014-03-181760
K110941REVOLIX JR 30, REVOLIX JR 50, REVOLIX JR 160, REVOLIX FR 200Allmed Systems, Inc.2013-02-196870
K070924FLEXGUARDAllmed Systems, Inc.2007-06-21790
K070466REVOLIX DUO LASER SYSTEMAllmed Systems, Inc.2007-04-17600
K070476REVOLIX 120Allmed Systems, Inc.2007-03-26340
K051167REVOLIX AND REVOLIX JRAllmed Systems, Inc.2005-06-01270
K033437SPHINX LASER SYSTEMSAllmed Systems, Inc.2004-01-20840
K033423REVOLIX LASER SYSTEMSAllmed Systems, Inc.2004-01-15800

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