Atlas FDA

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

EXY — Predicate Candidate Screening

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

93 daysmedian FDA review time
148 days90th percentile
16clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K142425UroflowmeterBe Technologies, Inc.2014-10-27590
K022721UROPOWERW.O.M. World of Medicine AG2003-08-263750
K971913GR100F URINE FLOWMETERAlbyn Medical , Ltd.1997-09-191200
K953999DANTEC DA CAPODantec Medical, Inc.1995-11-21890
K951442FLOLABSynectics Medical, Inc.1995-08-241480
K944972URO-GRAM CYSTOMRTROGRAM WITH UROFLOWMETRYMyo/Kinetic Systems, Inc.1995-03-081480
K9454954-CHANNEL URODYNAMIC MONITOR WITH URO-FLO OPTIONFiberoptic Sensor Technlogies, Inc.1995-02-09930
K941105UORCAP,MODEL NUMBER UDS-UCAPLaborie Medical Tech, Inc.1994-05-10640
K904557MICROFLOLife-Tech Intl., Inc.1990-12-28840
K902408DIAGNOSTIC ULTRASOUND UFS 1005Diagnostic Ultrasound Corp.1990-08-10710
K900770HOME URODATA SYSTEM(TM)Biodan Medical Systems, Ltd.1990-06-081120
K894968ULTRACOMPACTEutectic Electronics, Inc.1989-11-08930
K880504MCT MEDICAL BROWNE UROSCAN URODYNAMICMct Medical, Inc.1988-06-171330
K873695MODEL 1859 TUMI/PRESSURE MODULELife-Tech Intl., Inc.1988-01-271350
K872077MODEL 1858 CAVRO/PRESSURE MODULELife-Tech Intl., Inc.1987-08-27900
K770897URODYNAMIC INSTRUMENTSLife-Tech Instruments, Inc.1977-06-03180

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