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

Trace America, Inc. — Predicate Candidate Screening

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

58 daysmedian FDA review time

203 days90th percentile

22clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K003583	LITHIUM REGENT MODEL TR66056 / LITHIUM STANDARD TR66901	Trace America, Inc.	2001-01-17	58	0
K980026	GLUCOSE (HK) - INCORPORATING DYNAMIC STABILIZATION TECHNOLOG	Trace America, Inc.	1998-03-10	64	0
K980028	ALT (GPT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABI	Trace America, Inc.	1998-02-02	28	0
K980030	AST )GOT) LIQUID STABLE 2 VIAL - INCORPORATING DYNAMIC STABI	Trace America, Inc.	1998-01-30	25	0
K973869	TRACE REAGENT LINE FOR THE COBAS MIRA	Trace America, Inc.	1998-01-07	105	0
K974620	AMMONIA-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY (DST)	Trace America, Inc.	1998-01-02	22	1
K972297	AMYLASE-INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY - (DS	Trace America, Inc.	1997-07-17	28	0
K971477	UREA (UREA NITROGEN) - INCORPORATING DYNAMIC STABILIZATION T	Trace America, Inc.	1997-05-27	34	0
K971485	URIC ACID - INCORPORATING DYNAMIC STABILIZATION TECHNOLOGY -	Trace America, Inc.	1997-05-27	34	0
K962723	TRACE HDL CHOLESTEROL - AUTOMATED (HOMOGEN	Trace America, Inc.	1997-03-13	241	0
K961984	PORPHOBILINOGEN (PBG)	Trace America, Inc.	1996-12-10	203	0
K961477	TRIGLYCERIDES - INCORPORATING DYNAMIC STABILIZATION TECHNOLO	Trace America, Inc.	1996-08-05	109	0
K960035	CARBON DIOXIDE - DST	Trace America, Inc.	1996-04-08	96	0
K953971	TRIGLYCERIDES LIQUID STABLE INCORPORATING DYNAMIC STABILISAT	Trace America, Inc.	1996-04-05	226	0
K952410	CARBON DIOXIDE - DST	Trace America, Inc.	1995-10-05	134	0
K925794	TRACE MICROPROTEIN REAGENT	Trace America, Inc.	1993-03-29	133	0
K920603	TRACE MAGNESIUM - ARSENAZO REAGENT	Trace America, Inc.	1992-03-11	39	0
K895381	HDL SINGLES	Trace America, Inc.	1989-11-08	71	0
K880796	ALKALINE PHOSPHATASE REAGENT, DEA BUFF	Trace America, Inc.	1988-04-18	52	0
K880795	RESUBMITTED ALKALINE PHOSPHATASE REAGENT AMP BUFF.	Trace America, Inc.	1988-04-18	52	0
K880798	ACID PHOSPHATASE REAGENT	Trace America, Inc.	1988-04-18	52	0
K880794	RESUBMITTED BICARBONATE (CO2) REAGENT SINGLE VIAL	Trace America, Inc.	1988-04-18	52	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