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

Spacelabs Medical, Inc. · Predicate Candidate Screening

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

151 daysmedian FDA review time
383 days90th percentile
35clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K120616SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390Spacelabs Medical, Inc.2012-03-29299
K112962SPACELABS HEALTHCARE XPREZZON BESIDE MONITOR(9913930)Spacelabs Medical, Inc.2011-11-02287
K102422SPACELABS MEDICAL PATIENT MONITORSSpacelabs Medical, Inc.2010-12-071043
K093501ELANCE VITAL SIGNS MONITOR AND ELANCE CENTRAL STATIONSpacelabs Medical, Inc.2009-11-24122
K082045MODIFICATION TO MCARE 300 VITAL SIGNS MONITOR, MODEL 91220Spacelabs Medical, Inc.2008-08-01141
K063490SPACELABS MEDICAL FULL DISCLOSURE SYSTEM, MODEL 91810Spacelabs Medical, Inc.2007-03-151181
K062095MCARE 300 VITAL SIGNS MONITOR, MODEL 91220Spacelabs Medical, Inc.2006-09-29670
K062278SPACELABS MEDICAL CLINICAL EVENT INTERFACE, MODEL 91847Spacelabs Medical, Inc.2006-09-19430
K060900SPACELABS MEDICAL BISPECTRAL INDEX (BISX) ANALYSIS MODULE 91Spacelabs Medical, Inc.2006-06-23810
K053599SPACELABS MEDICAL MULTIGAS ANALYZER MODULE 91518 AND ACCESSOSpacelabs Medical, Inc.2006-04-191172
K050605SPACELABS MEDICAL MULTIPARAMETER MODULE 91496Spacelabs Medical, Inc.2005-05-03541
K050175SPACELABS MEDICAL MULTIPARAMETER MODULE 91496Spacelabs Medical, Inc.2005-03-04370
K013046COSMOS SYSTEMSpacelabs Medical, Inc.2002-08-213450
K021097QUEST EXERCISE STRESS SYSTEM (QUEST), VERSION 3.52Spacelabs Medical, Inc.2002-06-28850
K003663SPACELABS MEDICAL ANESTHESIA DELIVERY SYSTEM (ADS) WITH PRESSpacelabs Medical, Inc.2001-06-282120
K992749ULTRAVIEW WAVEFORM PAGER SYSTEM, MODEL 91841Spacelabs Medical, Inc.2000-01-141510
K981655SPACELABS MEDICAL DISPOSABLE SP02 SENSORSpacelabs Medical, Inc.1999-12-035710
K983996SPACELABS MEDICAL ULTRAVIEW DIGITAL TELEMTRY SYSTEMSpacelabs Medical, Inc.1999-06-032050
K981530SPACELABS MEDICAL 90519 ANESTHESIA DELIVERY SYSTEMSpacelabs Medical, Inc.1998-11-202050
K972502SPACELABS MEDICAL INTEGRATED MULTIPARAMETER MODULE 90496Spacelabs Medical, Inc.1998-05-283293
K973596SPACELABS MEDICAL 90482 BISPECTRAL INDEX ANALYSIS (BIS) MODUSpacelabs Medical, Inc.1998-02-031340
K965008BIRTHNET II PERINATAL PATIENT DATA MANAGEMENT SYSTEMSpacelabs Medical, Inc.1997-12-163651
K972282SPACELABS MEDICAL PCIS PATIENT MONITORSSpacelabs Medical, Inc.1997-09-25994
K962811SPACELABS MEDICAL MULTI-DISCLOSURE WORKSTATIONSpacelabs Medical, Inc.1997-06-243410
K962930SPACELABS MEDICAL ECG ANALYSIS SYSTEMSpacelabs Medical, Inc.1997-04-252700
K952912SPACELABS MEDICAL INTEGRATED MULTI-PARAMETER MODULESpacelabs Medical, Inc.1997-04-026460
K962970SPACELABS MEDICAL 12-LEAD DIAGNOSTIC ECG ANALYSIS OPTIONSpacelabs Medical, Inc.1997-03-252370
K952885SINGLE LEAD DIGITAL TELEMETRY TRANSMITTERSpacelabs Medical, Inc.1995-09-26950
K945429SPACELABS MEDICAL EXPANSION MODULE (MODEL 90352)Spacelabs Medical, Inc.1995-08-152810
K942058SPACELABS MEDICAL ECG MODULE (MODEL 90492)Spacelabs Medical, Inc.1995-05-173830
K941167NON-INVASIVE BLOOD PRESSURE (NIBP) MONITOR (MODEL 90553)Spacelabs Medical, Inc.1994-11-142450
K925510MODEL 90478 & 90479 TELEMETRY REC. MODULE&HOUSINGSpacelabs Medical, Inc.1994-10-277272
K932842SPACELABS MEDICAL MODEL 90481 EEG MODULESpacelabs Medical, Inc.1994-03-022640
K932724SPACELABS MEDICAL INTEGRATED CLINICAL DISPLAYSpacelabs Medical, Inc.1993-11-051514
K930095SPACELABS MEDICAL PATIENT MONITORSpacelabs Medical, Inc.1993-09-032380

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