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

Remel, Inc. — Predicate Candidate Screening

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

88 daysmedian FDA review time

280 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K162620	Remel Spectra ESBL	Remel, Inc.	2017-05-01	223	0
K131804	REMEL XPECT FLU A&B	Remel, Inc.	2013-07-12	23	0
K092407	REMEL SPECTRA MRSA	Remel, Inc.	2010-10-08	428	1
K072827	RPMI 1640 AGAR W/MOPS AND 2% GLUCOSE	Remel, Inc.	2007-11-26	54	0
K041951	XPECT CLOSTRIDIUM DIFFICILE TOXIN A/B	Remel, Inc.	2004-11-15	118	0
K033479	PROSPECT CLOSTRIDIUM DIFFICILE TOXIN A/B MICROPLATE ASSAY	Remel, Inc.	2004-02-26	115	0
K031942	XPECT GIARDIA LATERAL FLOW ASSAY, MODEL 2450020	Remel, Inc.	2003-11-18	147	0
K031965	XPECT CRYPTOSPORIDIUM LATERAL FLOW ASSAY, MODEL 2451020	Remel, Inc.	2003-11-14	141	1
K031834	XPECT GIARDIA/CRYPTOSPORIDIUM LATERAL FLOW ASSAY	Remel, Inc.	2003-11-10	150	1
K031565	XPECT INFLUENZA A/B	Remel, Inc.	2003-07-17	59	0
K981391	PAR-ONE	Remel, Inc.	1998-07-14	88	0
K970832	PYR SWAB	Remel, Inc.	1997-04-24	48	0
K970834	GRAM SWAB	Remel, Inc.	1997-04-17	41	0
K970830	REMEL LEVOFLOXACIN 5G SUSCEPTIBILTY DISK	Remel, Inc.	1997-04-02	26	0
K970833	INDOLE SWAB	Remel, Inc.	1997-04-02	26	0
K970831	REMEL SPARFLOXACIN 5G SUSCEPTIBILTY DISK	Remel, Inc.	1997-04-02	26	0
K935975	REMEL PIPERACILLIN/TAZOBACTAM 100/10 MCG	Remel, Inc.	1994-09-19	280	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