Atlas FDA

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

Signal Medical Corp. · Predicate Candidate Screening

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

90 daysmedian FDA review time
388 days90th percentile
9clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K100370SYMMETRIC TOTAL KNEE AGUMENTSSignal Medical Corp.2011-03-073880
K073674BONE FIXATION WIRE (KIRSCHNER WIRE)Signal Medical Corp.2008-03-24870
K051510SIGNAL MEDICAL CORPORATION BEACON KNEE SYSTEMSignal Medical Corp.2006-03-222880
K043289E-Z FRAME EXTERNAL SURGICAL SUPPORT BOOTSignal Medical Corp.2005-02-11740
K022382RHS ACETABULAR COMPONENTSignal Medical Corp.2002-10-04740
K021063GREAT TOE IMPLANTSignal Medical Corp.2002-07-01900
K981302SMC 28MM CERAMIC FEMORAL HEADSSignal Medical Corp.1998-06-25770
K971681SMC FEMORAL HIP COMPONENTSignal Medical Corp.1997-12-042120
K971018SMC ACETABULAR COMPONENTSignal Medical Corp.1997-10-242180

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