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

MSW — Predicate Candidate Screening

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

153 daysmedian FDA review time

458 days90th percentile

13clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K242981	Atellica IM Thyroglobulin (Tg)	Siemens Healthcare Diagnostics, Inc.	2025-06-20	267	0
K240927	Access Thyroglobulin	Beckman Coulter, Inc.	2024-06-28	85	0
K241423	Access Thyroglobulin	Beckman Coulter, Inc.	2024-06-07	18	0
K221890	Elecsys Tg II	Roche Diagnostics	2023-09-30	458	0
K220972	Access Thyroglobulin	Beckman Coulter, Inc.	2023-09-15	529	0
K031269	ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS IMMUNOASSAY SYST	Beckman Coulter, Inc.	2003-05-02	11	5
K021057	BRAHMS DIAGNOSTICA DYNOTEST TG-PLUS	Brahms Diagnostica, LLC	2002-09-17	169	0
K002888	NICHOLS ADVANTAGE THYROGLOB	Nichols Institute Diagnostics	2000-10-20	35	0
K002905	ACCESS THYROGLOBULIN REAGENTS ON THE ACCESS ANALYZER	Beckman Coulter, Inc.	2000-10-19	31	3
K994140	NICHOLS CHEMILUMINESCENCE THYROGLOBULIN, MODEL 60-4240	Nichols Institute Diagnostics	2000-05-09	153	0
K991720	KRONUS OPTIQUANT THYROGLOBULIN KIT	Unchanged	1999-08-09	81	0
K982466	IMMULITE THYROGLOBULIN MODEL LKTY	Diagnostic Products Corp.	1999-03-12	240	1
K982468	IMMULITE 2000 THYROGLOBULIN MODEL L2KTY	Diagnostic Products Corp.	1999-03-12	240	3

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