Atlas FDA

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

Cas Medical Systems, Inc. · Predicate Candidate Screening

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

120 daysmedian FDA review time
329 days90th percentile
32clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K190270FORE-SIGHT ELITE Tissue Oximeter ModuleCas Medical Systems, Inc.2019-10-212550
K180003FORE-SIGHT ELITE Module Tissue OximeterCas Medical Systems, Inc.2018-05-101280
K150620740 SELECTCas Medical Systems, Inc.2015-05-08591
K143675FORE-SIGHT Elite Absolute Tissue OximeterCas Medical Systems, Inc.2015-04-101070
K140430740 SELECTCas Medical Systems, Inc.2014-06-131140
K133879FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETERCas Medical Systems, Inc.2014-04-291300
K130411740 SELECTCas Medical Systems, Inc.2013-05-29990
K123700FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETERCas Medical Systems, Inc.2013-04-111290
K112820FORE-SIGHT ABSOLUTE TISSUE OXIMETERCas Medical Systems, Inc.2012-01-261200
K094030FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SCas Medical Systems, Inc.2010-12-233580
K091452FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MCas Medical Systems, Inc.2009-08-21950
K083892FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, Cas Medical Systems, Inc.2009-03-19800
K073036FORE-SIGHT, MC-2000 SERIESCas Medical Systems, Inc.2008-02-251190
K063087MODIFICATION TO MODEL 750 SERIES MONITORCas Medical Systems, Inc.2006-12-11620
K061960FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040Cas Medical Systems, Inc.2006-09-05560
K051257ADULT CEREBRAL OXIMETER, MODEL 2040Cas Medical Systems, Inc.2005-12-222200
K051896MODEL 750E SERIES MONITORCas Medical Systems, Inc.2005-12-161560
K050844750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 7Cas Medical Systems, Inc.2005-06-23800
K033048CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-Cas Medical Systems, Inc.2004-06-012461
K000512OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1Cas Medical Systems, Inc.2000-09-262230
K9827769303 NEONATAL/ADULT VITAL SIGNS MONITORCas Medical Systems, Inc.1998-11-02880
K982135OSCILLOMATE EMS NIBP MONITOR MODEL 9001Cas Medical Systems, Inc.1998-09-15900
K980879OSCILLOMATE NIBP / SP02 EMS MONITORCas Medical Systems, Inc.1998-07-161290
K972020OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITORCas Medical Systems, Inc.1998-05-053370
K926030KLEAR-TEMPCas Medical Systems, Inc.1994-02-244500
K925402OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9300Cas Medical Systems, Inc.1993-09-173290
K911722OSCILLOMATE (TM) BLOOD PRESSURE MONITOR-MODEL 1630Cas Medical Systems, Inc.1992-01-222800
K860488OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915Cas Medical Systems, Inc.1986-08-251960
K861364NEOGUARD ECG ELECTRODESCas Medical Systems, Inc.1986-08-061170
K860196OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901Cas Medical Systems, Inc.1986-05-121100
K853965NEOGUARD CHEST PERCUSSORCas Medical Systems, Inc.1985-12-03680
K853794NEOGUARD REFLECTORCas Medical Systems, Inc.1985-10-16350

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