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

MLD — Predicate Candidate Screening

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

146 daysmedian FDA review time

553 days90th percentile

14clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K101602	VITAL SIGNS MONITOR	Criticare Systems, Inc.	2010-09-01	85	0
K080461	STAR ST AND ARRHYTHMIA SOFTWARE, RELEASE J.0	Philips Medical Systems	2008-03-13	22	0
K022740	DATEX-OHMEDA S/5 COMPACT CRITICAL CARE MONITOR WITH L-CICU02	Datex-Ohmeda	2002-11-14	87	2
K012837	MODIFICATION TO: DATEX-OHMEDA CARDIOCAP 5 (REV B) AND ACCESS	Datex-Ohmeda	2001-09-14	22	2
K002105	SIEMENS INFINITY SC 6002XL ENHANCED WITH ST SEGMENT ANALYSIS	Siemens Medical Solutions USA, Inc.	2000-12-05	146	0
K992323	DATEX-OHMEDA CARDIOCAP 5, F-MX, F-MXG AND ACCESSORIES	Datex-Ohmeda, Inc.	1999-11-01	112	1
K982104	ESCORT-LINK CENTRAL STATION MONITOR MODEL 20500	Medical Data Electronics	1998-11-25	163	0
K974492	SIEMENS SC6000/SC6000P BEDSIDE MONITORING SYSTEM ENHANCED WI	Siemens Medical Solutions USA, Inc.	1998-02-26	90	0
K972121	ACUITY CENTRAL STATION	Protocol Systems, Inc.	1997-11-07	155	0
K953175	AS/3 ESTPR MODULE	Datex Division Instrumentarium Corp.	1997-02-06	580	0
K960272	EAGLE 3000/3100 PATIENT MONITOR	Marquette Electronics, Inc.	1996-10-02	258	0
K960934	HP M1205A OMNICARE COMPONENT MONITOR SYSTEM MODEL 24	Hewlett-Packard Co.	1996-06-14	98	0
K935020	OMNI-TRAC MODIFICATION	Invivo Research, Inc.	1995-04-26	553	0
K920429	MODIFIED MODEL M1403A TELEMETRY MONITORING SYSTEM	Hewlett-Packard Co.	1993-07-20	533	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