Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account

KRC — Predicate Candidate Screening

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

61 daysmedian FDA review time

278 days90th percentile

11clearances measured

K-number	Device	Applicant	Decided	Review days
K023713	SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000	Sontra Medical, Inc.	2004-01-28	450
K872370	BIOMA 3500	E.B.S., Inc.	1987-12-07	171
K874155	CIRCAMED MONITOR REMOTE START CONDUCTANCE METER	Circadian, Inc.	1987-11-23	41
K874327	SKIN PREP ANALYZER	Marquette Electronics, Inc.	1987-11-23	33
K840358	IMPEDANCE/8200 MONITOR-MODEL 8300	Aequitron Medical, Inc.	1984-10-30	278
K833619	CONDUCTANCE METER	Circadian, Inc.	1984-01-27	105
K830876	PREP-CHECK	General Devices	1983-05-18	61
K830823	Z VIEW METER MODEL 300	Lintronics Industries, Inc.	1983-05-18	64
K813358	GERARD MEDICAL ELECTRODE TESTER	Gerard Medical Enterprises, Inc.	1981-12-29	29
K780501	ELECTRODE TESTER	Mg Medical Electronics	1978-05-19	52
K771014	TS-100 TEST SYSTEM	Delta Medical Industries	1977-06-14	8

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