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

Spacelabs, Inc. — Predicate Candidate Screening

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

80 daysmedian FDA review time
214 days90th percentile
46clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K954962SPACELABS MEDICAL MULTIGAS ANALYZERSpacelabs, Inc.1996-05-312140
K951605SPACELABS MEDICAL CASEMASTER INFORMATION MANAGEMENT SYSTEMSpacelabs, Inc.1995-07-14980
K950779HEART RATE VARIABILITY SOFTWARE OPTIONSpacelabs, Inc.1995-04-25630
K941165COMET CAPNOGRAPH MODULESpacelabs, Inc.1994-10-062090
K923788SPACE LABS MODEL 90560Spacelabs, Inc.1993-12-064960
K912742ESOPHAGEAL STETHOSCOPE TEMPERATURE PROBESpacelabs, Inc.1992-04-203040
K913038SPACELAB MODEL 90845 PCMS MULTIDISCLOSURE STATIONSpacelabs, Inc.1991-10-04870
K905065DEFIBRILLATOR LEAD ADAPTERSpacelabs, Inc.1991-04-121560
K910029PATIENT CARE MANAGEMENT SYSTEM MODIFICATIONSpacelabs, Inc.1991-01-31280
K896903FIRST MEDIC MODEL 510Spacelabs, Inc.1990-12-273840
K904318LOCAL REPORT GENERATORSpacelabs, Inc.1990-12-18890
K903702MODEL 90421 FLEXPORT INTERFACESpacelabs, Inc.1990-10-19801
K901209MODEL 90489 PULSE OXIMETER MODULESpacelabs, Inc.1990-04-30470
K896942SPACELABS MODEL 90480 EEG MODULESpacelabs, Inc.1990-03-08850
K896427SPACELABS' MODEL 90514, MULTIGAS ANALYZERSpacelabs, Inc.1990-01-24770
K894093SPACELABS MODEL 90900Spacelabs, Inc.1989-11-301740
K893867CARDIAC OUTPUR/SATURATED VENOUS OXYGEN MODULESpacelabs, Inc.1989-09-131100
K864279SPACELABS MODEL 90419 PULSE OXIMETER MODULESpacelabs, Inc.1987-03-111320
K864506SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1Spacelabs, Inc.1986-11-25110
K864505SPACELABS ARRHYTHMIA NET (TM) LEVEL 2Spacelabs, Inc.1986-11-24100
K862951SPACELABS SERIES 90700 PATIENT MONITORSSpacelabs, Inc.1986-09-23490
K855127AMBULATORY BLOOD PRESSURE MONITOR SPACELABS #90202Spacelabs, Inc.1986-08-142340
K860689SPACELABS P.C. CARDIAC OUTPUT/PRESSURE MODULESpacelabs, Inc.1986-07-301550
K860980PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA IIISpacelabs, Inc.1986-05-21710
K860834SPACELABS MEDICAL WORKSTATIONSpacelabs, Inc.1986-04-29550
K860352SPACELABS AIRWAY ADAPTER SET SERIES, NO. 369014Spacelabs, Inc.1986-03-19480
K850627SPACELABS-GENERAL SYSTEM LINKSpacelabs, Inc.1985-05-28980
K844940SPACELABS MODEL 90201 HOLTER RECORDERSpacelabs, Inc.1985-02-14560
K844888SPACELABS SERIES 600 PATIENT MONITORSSpacelabs, Inc.1985-02-01460
K842616SPACELABS ALPHA PC PATIENT COMPUTERSpacelabs, Inc.1984-10-181052
K842640SPACELABS ICR ARRHYTHMIA MASTER I HOLTERSpacelabs, Inc.1984-10-04860
K842978540 CAPNOGRAPHSpacelabs, Inc.1984-08-24250
K834597ALPHA MASS STORAGE CARDULE 1895Spacelabs, Inc.1984-04-171090
K834460MODEL 1888 ALPHA COS/RESPIRATION CARSpacelabs, Inc.1984-02-13560
K832644ALPHA CARDIAC OUTPUT CARDULE #1899Spacelabs, Inc.1984-01-271750
K832764ALPHA NON-INVASIVE BP CARDULESpacelabs, Inc.1984-01-271640
K832693ARRHYTHMIA III CARDULE #1919Spacelabs, Inc.1983-11-07890
K830306HEARTRATE PLUS ECG CARDULE #1918Spacelabs, Inc.1983-03-17450
K811540SPACELABS' SYSTEM AUTORECORDERSpacelabs, Inc.1981-08-13730
K791776ARRHYTHMIA II EDITORSpacelabs, Inc.1979-10-02220
K790837ARRHYTHMIA II CARDULESpacelabs, Inc.1979-05-16160
K781836TELEMETRY SYSTEM, BIOTEL 300Spacelabs, Inc.1978-12-04350
K761244SERIES 700 PATIENT MONITORSSpacelabs, Inc.1976-12-23100
K760884MICRO-COMPUTER ARRHYTHONIA SYSTEMSpacelabs, Inc.1976-12-09480
K760612SPACELABS SERIES 1000Spacelabs, Inc.1976-09-21110
K760120PULSE CARDULE (MODEL 1859/1860 ECG)Spacelabs, Inc.1976-07-20220

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