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

LKS — Predicate Candidate Screening

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

61 daysmedian FDA review time

223 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days
K053257	PARA-PRO FC50	Alpha-Tec Systems, Inc.	2006-05-12	171
K021420	PARACON II/FECAL CONCENTRATOR II	Para Scientific Co.	2002-06-04	32
K980077	PARA-PAK SPINCON	Meridian Diagnostics, Inc.	1998-04-02	84
K941110	PARAKIT	Hardy Diagnostics	1994-05-17	71
K941129	CON-KIT	Medical Chemical Corp.	1994-05-09	61
K933370	STOOL TRANSPORT/PROCESSOR	Sage Products, Inc.	1994-02-17	223
K935316	PARASAFE(R) FIXATIVE	Scientific Device Laboratory, Inc.	1994-02-17	107
K931849	PARAPREP	Medastat Scientific Corp.	1993-12-02	233
K881649	MODIFIED PARACON(TM) CONCENTRATION KIT	Para Scientific Co.	1988-04-21	6
K860034	PARA-PAK MACRO-CON	Meridian Diagnostics, Inc.	1986-02-21	46
K853715	PARA CON TM	Para Scientific Co.	1985-10-02	28
K833469	FPC FECAL PARASITE CONCENTRATOR	Evergreen Scientific, Inc.	1983-11-28	53
K831365	TESTCORP ANA	Catheter Technology Corp.	1983-06-02	37

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