Company ยท US
Cas Medical Systems, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1985 to 2019. Name variants (Inc, Corp, punctuation) are merged.
32510(k) clearances (0 in 12 months)
13recalls (0 in 12 months)
13recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| KZD | Infusor, Pressure, For I.V. Bags | 11 |
| MUD | Oximeter, Tissue Saturation | 9 |
| DQA | Oximeter | 6 |
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 6 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 5 |
| FMT | Warmer, Infant Radiant | 2 |
| MHX | Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | 2 |
| BYI | Percussor, Powered-Electric | 1 |
| BZQ | Monitor, Breathing Frequency | 1 |
| DXQ | Blood Pressure Cuff | 1 |
| DXW | System, Phonocatheter, Intracavitary | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 21, 2019 | K190270 | FORE-SIGHT ELITE Tissue Oximeter Module Cas Medical Systems, Inc. | MUD |
| May 10, 2018 | K180003 | FORE-SIGHT ELITE Module Tissue Oximeter Cas Medical Systems, Inc. | MUD |
| May 8, 2015 | K150620 | 740 SELECT Cas Medical Systems, Inc. | MWI |
| Apr 10, 2015 | K143675 | FORE-SIGHT Elite Absolute Tissue Oximeter Cas Medical Systems, Inc. | MUD |
| Jun 13, 2014 | K140430 | 740 SELECT Cas Medical Systems, Inc. | MWI |
| Apr 29, 2014 | K133879 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER Cas Medical Systems, Inc. | MUD |
| May 29, 2013 | K130411 | 740 SELECT Cas Medical Systems, Inc. | MWI |
| Apr 11, 2013 | K123700 | FORE-SIGHT ELITE ABSOLUTE TISSUE OXIMETER Cas Medical Systems, Inc. | MUD |
| Jan 26, 2012 | K112820 | FORE-SIGHT ABSOLUTE TISSUE OXIMETER Cas Medical Systems, Inc. | MUD |
| Dec 23, 2010 | K094030 | FORE-SIGHT ABSOLUTE CEREBRAL AND SOMATIC OXIMETER, MC 2000 SERIES, MODELS MC2000, MC2010, MC2020, MC2030 Cas Medical Systems, Inc. | MUD |
| Aug 21, 2009 | K091452 | FORE-SIGHT, MODEL MC-2000 SERIES (MC 2000, MC2010, MC-2020,MC2030) Cas Medical Systems, Inc. | MUD |
| Mar 19, 2009 | K083892 | FORE-SIGHT, MODEL MC-2000 SERIES (MC-2000, MC-2010, MC2020, MC2030) Cas Medical Systems, Inc. | DQA |
| Feb 25, 2008 | K073036 | FORE-SIGHT, MC-2000 SERIES Cas Medical Systems, Inc. | DQA |
| Dec 11, 2006 | K063087 | MODIFICATION TO MODEL 750 SERIES MONITOR Cas Medical Systems, Inc. | MWI |
| Sep 5, 2006 | K061960 | FORE-SIGHT CEREBRAL OXIMETER MONITOR, MODEL 2040 Cas Medical Systems, Inc. | MUD |
| Dec 22, 2005 | K051257 | ADULT CEREBRAL OXIMETER, MODEL 2040 Cas Medical Systems, Inc. | DQA |
| Dec 16, 2005 | K051896 | MODEL 750E SERIES MONITOR Cas Medical Systems, Inc. | MWI |
| Jun 23, 2005 | K050844 | 750C SERIES MONITOR, MODELS 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL, 750C-3MS, 750CM-3MS, 750C-3NL, 750CM-3NL Cas Medical Systems, Inc. | DQA |
| Jun 1, 2004 | K033048 | CAS 740 SERIES MONITOR, MODELS 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS Cas Medical Systems, Inc. | MHX |
| Sep 26, 2000 | K000512 | OSCILLOMITT, MODELS CM 1050, CM 1040, CM 1030, CM 1020, CM 1010 Cas Medical Systems, Inc. | DXQ |
| Nov 2, 1998 | K982776 | 9303 NEONATAL/ADULT VITAL SIGNS MONITOR Cas Medical Systems, Inc. | DQA |
| Sep 15, 1998 | K982135 | OSCILLOMATE EMS NIBP MONITOR MODEL 9001 Cas Medical Systems, Inc. | DXN |
| Jul 16, 1998 | K980879 | OSCILLOMATE NIBP / SP02 EMS MONITOR Cas Medical Systems, Inc. | DQA |
| May 5, 1998 | K972020 | OSCILLOMATE NON-INVASIVE BLOOD PRESSURE MONITOR Cas Medical Systems, Inc. | DXW |
| Feb 24, 1994 | K926030 | KLEAR-TEMP Cas Medical Systems, Inc. | FMT |
| Sep 17, 1993 | K925402 | OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 9300 Cas Medical Systems, Inc. | DXN |
| Jan 22, 1992 | K911722 | OSCILLOMATE (TM) BLOOD PRESSURE MONITOR-MODEL 1630 Cas Medical Systems, Inc. | DXN |
| Aug 25, 1986 | K860488 | OSCILLOMATE BLOOD PRESSURE MONITOR-MODEL 915 Cas Medical Systems, Inc. | DXN |
| Aug 6, 1986 | K861364 | NEOGUARD ECG ELECTRODES Cas Medical Systems, Inc. | DXN |
| May 12, 1986 | K860196 | OSCILLOMATE NEONATAL BLOOD PRESS. MONIT.-MODEL 901 Cas Medical Systems, Inc. | DXN |
| Dec 3, 1985 | K853965 | NEOGUARD CHEST PERCUSSOR Cas Medical Systems, Inc. | BYI |
| Oct 16, 1985 | K853794 | NEOGUARD REFLECTOR Cas Medical Systems, Inc. | FMT |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 29, 2008 | CAS Medical Systems, Inc. CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve. Model: D803FGA. Private labeled for P.J. Dahlhausen in Germany. It is designed for use in rapid infusion,invasive pressure mon Terminated |
KZD | K893519 |
| Dec 29, 2008 | CAS Medical Systems, Inc. CASMED 500cc Unifusor II with aneroid gauge and thumbwheel valve. Private labeled for Transmed in Germany. Model: T2803SGA. It is designed for use in rapid infusion,invasive pressure monitoring an Terminated |
KZD | K893519 |
| Dec 29, 2008 | CAS Medical Systems, Inc. CASMED 500cc Unifusor with a short tube. Private labeled for King Systems.
Model: P500BAG. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. Terminated |
KZD | K893519 |
| Dec 29, 2008 | CAS Medical Systems, Inc. CASMED 500cc Unifusor Classic with aneroid gauge and thumbwheel valve
Model:FN-803FGA. Private labeled for Femcare-Nikomed in the UK. It is designed for use in rapid infusion,invasive pressure mo Terminated |
KZD | K893519 |
| Dec 29, 2008 | CAS Medical Systems, Inc. CASMED 500cc Unifusor Classic with piston gauge and stopcock valve
Model: 903SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. Terminated |
KZD | K893519 |
| Dec 29, 2008 | CAS Medical Systems, Inc. CASMED 500cc Unifusor Classic with piston gauge and stopcock valve.
Model : A903SGA. The letter A refers to a special quantity designator for a particular customer. It is designed for use in rapid Terminated |
KZD | K893519 |
| Dec 29, 2008 | CAS Medical Systems, Inc. CASMED 500cc Unifusor with aneroid gauge and stopcock valve.
Model: 803SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. Terminated |
KZD | K893519 |
| Dec 29, 2008 | CAS Medical Systems, Inc. Casmed 500cc Unifusor II with aneroid gauge and thumbwheel valve
Model: 2803SGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. Terminated |
KZD | K893519 |
| Dec 29, 2008 | CAS Medical Systems, Inc. CASMED 500cc Unifusor with aneroid gauge and stopcock valve.
Model: A803SGA . The letter A refers to a special quantity designator for a particular customer. The product is designed for use in rapi Terminated |
KZD | K893519 |
| Dec 29, 2008 | CAS Medical Systems, Inc. CASMED 500cc Unifusor with aneroid gauge and thumbwheel valve
Model: 803FGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. Terminated |
KZD | K893519 |
| Dec 29, 2008 | CAS Medical Systems, Inc. CASMED 500cc Unifusor Classic with piston gauge and thumbwheel valve.
Model: 903TGA. It is designed for use in rapid infusion,invasive pressure monitoring and with auto-transfusion devices. Terminated |
KZD | K893519 |
| Sep 16, 2008 | CAS Medical Systems, Inc. 740 Series Multiparameter Monitor Software Version 3.0
Model Numbers: 740-1, 740M-1, 740-2T, 740M-2T, 740-2MS, 740M-2MS, 740-2NL, 740M-2NL, 740-2NN, 740M-2NN, 740-3MS, 740M-3MS, 740-3NL, 740M-3NL, 740 Terminated |
MHX | K033048 |
| Jul 20, 2004 | CAS Medical Systems, Inc. Model 511 Cardio Respiratory Monitor with Oximax technology with software version 5.0 Terminated |
BZQ | K962781 |