Atlas FDA

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

Iomed, Inc. · Predicate Candidate Screening

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

140 daysmedian FDA review time
605 days90th percentile
17clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K063465CHAMPION IONTOPHORETIC DRUG DELIVERY DEVICEIomed, Inc.2007-02-281040
K060236MW-1000 IONTOPHORETIC DRUG DELIVERY ELECTRODEIomed, Inc.2006-03-31600
K033192RH-950Iomed, Inc.2003-12-22810
K031115RH-900Iomed, Inc.2003-07-10930
K001522TRANSQ3Iomed, Inc.2000-10-181550
K001410PHORESOR MODEL PM2000Iomed, Inc.2000-08-01890
K982668PHORESOR II,MODEL PM900Iomed, Inc.1999-03-022140
K974855PHORESOR II, MODEL PM900Iomed, Inc.1998-03-27880
K954126TRANSQ ELECTRODE PHORESOR IIIomed, Inc.1996-01-191400
K932621RH-801/GS MODEL TRANSQ(R)1Iomed, Inc.1994-07-264200
K934335PHORESOR II AUTO, MODEL PM800 MODIFICATIONIomed, Inc.1994-07-263220
K932620RH-806/GS MODEL TRANSQ(R)2Iomed, Inc.1994-07-264200
K925806RH-801, MODEL TRANSQIomed, Inc.1994-07-146050
K925800RH-806, MODEL TRANSQIomed, Inc.1994-07-146050
K914621IONTOPHORESIS DEVICE, MODIFICATIONIomed, Inc.1991-12-201000
K914264TRANSQ 2Iomed, Inc.1991-12-20880
K896444IONTOPHORESIS DEVICE - ELECTRODE RH 800Iomed, Inc.1990-05-101820

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