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

Hanson Medical, Inc. · Predicate Candidate Screening

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

49 daysmedian FDA review time
234 days90th percentile
14clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K141822SENSEI X ROBOTIC CATHETER SYSTEMHanson Medical, Inc.2014-08-05291
K090803HANSON MEDICAL FACIAL IMPLANTSHanson Medical, Inc.2010-06-304630
K071018MONARCH NASAL IMPLANTHanson Medical, Inc.2007-05-25450
K041690MONARCH NASAL IMPLANTHanson Medical, Inc.2005-02-112340
K040307HANSON SCAR ADEHanson Medical, Inc.2004-08-121850
K030808HANSON MEDICAL CALF IMPLANTHanson Medical, Inc.2003-04-21390
K030809HANSON MEDICAL GLUTEAL IMPLANTHanson Medical, Inc.2003-04-21390
K973730DURASIL I AND DURASIL IIHanson Medical, Inc.1997-12-24850
K973729POWERFLEX PEC IMPLANTHanson Medical, Inc.1997-12-24850
K973573DURALASTIC ANATOMICAL NASAL IMPLANTSHanson Medical, Inc.1997-11-13550
K973728SILICONE CARVING BLOCKHanson Medical, Inc.1997-11-13440
K973575DURALASTIC ANATOMICAL CHIN IMPLANTSHanson Medical, Inc.1997-11-07490
K973574DURALASTIC ANATOMICAL MALAR IMPLANTHanson Medical, Inc.1997-10-24350
K973572KELOCOTE SCAR GEL AND KELOCOTE LASER GELHanson Medical, Inc.1997-10-21320

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