Atlas FDA

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

HFG · Predicate Candidate Screening

11 FDA 510(k) clearances under this product code; the 50 most recent screened below.

132 daysmedian FDA review time
287 days90th percentile
11clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K181124Acessa ProVu SystemAcessa Health, Inc.2018-09-281510
K132744ACESSA GUIDANCE SYSTEMHalt Medical, Inc.2014-05-272660
K132184ACESSA GUIDANCE HANDPIECEHalt Medical, Inc.2014-04-282870
K121858THE ABLATION SYSTEMHalt Medical, Inc.2012-11-051320
K101606MICROMED PD-8K INSULATION DEFECT DETECTORMcgan Technology, LLC2010-10-011150
K991424INSULSCAN INSULATION TESTING SYSTEMMedicor Corp.1999-07-22900
K961695ENDO-TECH LTD., TIPSRatio Design Lab1996-07-01610
K921405DAVOL SUCTION/IRRIGATOR W/ INTERCHANGEABLE TIPDavol, Inc.1994-03-257310
K915406DAVOL ELECTROSUGICAL PROBESDavol, Inc.1992-02-28880
K904240SINGLE USE LAPARSCOPIC ELECTRODEAspen Labs1991-02-191590
K902555AMCATH COAGULATION PROBEIntl. Medical, Inc.1990-06-20120

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