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

MQM — Predicate Candidate Screening

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

193 daysmedian FDA review time

459 days90th percentile

17clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K170882	ABL90 FLEX, ABL90 FLEX PLUS	Radiometer Medical Aps	2017-04-28	35	0
K133175	DRAEGER JAUNDICE METER JM-105	Draeger Medical Systems, Inc.	2014-11-13	392	1
K132691	ABL90 FLEX	Radiometer Medical Aps	2014-11-13	442	0
K110277	RAPIDPOINT 405 NEONATAL BILIRUBIN	Siemens Healthcare Diagnostics	2011-08-15	196	4
K073537	NEONATAL BILIRUBIN ON RAPIDLAB MODELS 1245 AND 1265	Siemens Medical Solutions Diagnostics	2008-06-27	193	5
K042522	JAUNDICE METER, MODEL JM 103	Draeger Medical Infant Care, Inc.	2005-07-06	293	1
K040174	BILIRUBIN ASSAY ON THE OMNI S ANALYZER	Roche Diagnostics Corp.	2004-05-14	109	0
K021622	HILL-ROM AIR SHIELDS/MINOLTA JAUNDICE METER, MODEL JM-103	Hill-Rom Air-Shields	2003-04-01	320	0
K001687	COLORMATE TLC BILITEST SYSTEM	Chromatics Color Sciences Intl., Inc.	2001-09-13	469	0
K010052	RESPIRONICS BILICHEK NON-INVASIVE-100-0800-20; BILIRUBIN ANA	Respironics, Inc.	2001-03-19	70	0
K994438	BILICHEK NON-INVASIVE BILIRUBIN ANALYZER	Spectrx, Inc.	2000-02-04	36	0
K983071	BILICHEK NON-INVASIVE BILIRUBIN ANALYZER	Respironics, Inc.	1999-03-04	183	0
K983134	NBIL	Abbott Laboratories	1998-09-23	15	0
K972309	JM-102 JAUNDICE METER	Air-Shields, Inc.	1998-09-22	459	0
K980646	IL SYNTHESIS--ADDITION OF BILIRUBIN AS A MEASURED PARAMETER	Instrumentation Laboratory CO	1998-05-06	76	0
K964590	COLORMATE III	Chromatics Color Sciences Intl., Inc.	1997-07-24	251	0
K922770	UNISTAT BILIRUBINOMETER MODELS 10310 AND 10311	Leica, Inc.	1992-08-18	70	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