Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account

FKH · Predicate Candidate Screening

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

69 daysmedian FDA review time

134 days90th percentile

8clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K191496	TDS Standard Solution	Mesa Laboratories, Inc.	2019-08-05	61	0
K130100	COMINED STANDARD SOLUTION	Mesa Laboratories, Inc.	2013-04-18	93	0
K041636	H&S-CONDUCTIVITY STANDARD SOLUTION	H & S Technical Services	2004-07-02	15	1
K033330	CONDUCTIVITY/TDS CALIBRATOR SOLUTION	Mesa Laboratories, Inc.	2004-02-27	134	1
K032075	CONDUCTIVITY STANDARD SOLUTION-METERCARE	Ibp Instruments GmbH	2003-09-17	72	0
K863824	SOLUTION/TEST STANDARD/CONDUCT. DIALY.&MULT.SOLUT.	D.R.G. Scientific Industries	1986-10-24	24	0
K851362	STANDARD SOLUTION OF CONDUCTIVITY & MEASUREMENT OF	Rna Medical Corp.	1985-06-12	69	0
K812622	HEMODIALYSIS VENOUS & ARTERIAL SET	Amisco Trading Corp.	1981-09-24	9	0

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