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

KTB — Predicate Candidate Screening

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

88 daysmedian FDA review time

155 days90th percentile

16clearances measured

K-number	Device	Applicant	Decided	Review days
K180627	Macroduct Advanced Model 3710	Elitechgroup, Inc.	2018-07-27	140
K033192	RH-950	Iomed, Inc.	2003-12-22	81
K031551	NORTHSTAR LIDOCAINE IONTOPHORETIC CONTROLLER (NORTHSTAR CONT	Vyteris, Inc.	2003-08-20	93
K031115	RH-900	Iomed, Inc.	2003-07-10	93
K010031	NANODUCT NEONATAL SWEAT ANALYSIS SYSTEM	Wescor, Inc.	2001-03-20	76
K001522	TRANSQ3	Iomed, Inc.	2000-10-18	155
K001410	PHORESOR MODEL PM2000	Iomed, Inc.	2000-08-01	89
K992874	Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM	Wr Medical Electronics Co.	1999-11-18	84
K974855	PHORESOR II, MODEL PM900	Iomed, Inc.	1998-03-27	88
K954126	TRANSQ ELECTRODE PHORESOR II	Iomed, Inc.	1996-01-19	140
K895775	CF INDICATOR MODEL 9800 SWEAT TEST SYSTEM	Medtronic Vascular	1990-04-23	208
K853973	WESCOR MODEL 3700 WEBSTER SWEAT INDUCER	Wescor, Inc.	1985-10-16	20
K840472	SYS MACRODUCT SWEAT COLLECTION SYS 3600	Wescor, Inc.	1984-03-19	45
K832059	IONOPHORELIC SWEAT STIM. CHLORIDE-	Medtronic Vascular	1983-08-24	58
K790205	ELECTROAPPLICATOR MODEL C-1	Mcg, Inc.	1979-03-19	47
K781700	IONOTPHORETIC APPLICATOR	Mcghan Medical Corp.	1978-11-03	24

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