Company ยท US
Engineered Medical Systems
FDA 510(k) clearances and medical device recalls filed under this name, 1987 to 2022. Name variants (Inc, Corp, punctuation) are merged.
24510(k) clearances (0 in 12 months)
1recalls (0 in 12 months)
1recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 6 |
| BSJ | Mask, Gas, Anesthetic | 3 |
| BZD | Ventilator, Non-Continuous (Respirator) | 3 |
| BYE | Attachment, Breathing, Positive End Expiratory Pressure | 2 |
| CAH | Filter, Bacterial, Breathing-Circuit | 2 |
| BTO | Tube, Tracheostomy (W/Wo Connector) | 1 |
| BWF | Spirometer, Therapeutic (Incentive) | 1 |
| BYI | Percussor, Powered-Electric | 1 |
| BZG | Spirometer, Diagnostic | 1 |
| CAP | Monitor, Airway Pressure (Includes Gauge And/Or Alarm) | 1 |
| CBP | Valve, Non-Rebreathing | 1 |
| CCK | Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | 1 |
| JOH | Tube Tracheostomy And Tube Cuff | 1 |
| KNW | Instrument, Biopsy | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Nov 16, 2022 | K220533 | Endoscopy Oxygen Mask Engineered Medical Systems, Inc. | CCK |
| Apr 20, 2007 | K062104 | TALKING TRACH Engineered Medical Systems, Inc. | BTO |
| Dec 1, 2003 | K023683 | MULTI-STRAP FULL FACE MASK Engineered Medical Systems | BZD |
| Jul 30, 2002 | K013728 | TRACH VOX Engineered Medical Systems | JOH |
| Apr 19, 2002 | K013122 | EMS ELECTROSTATIC FLITER AND HME COMBINATION Engineered Medical Systems | CAH |
| Mar 14, 2002 | K013123 | EMS PULMONARY FUNCTION TESTING FILTER Engineered Medical Systems | BZG |
| Mar 14, 2002 | K013089 | EMS HEPA FILTER AND HME COMBINATIONS Engineered Medical Systems | CAH |
| Nov 30, 2000 | K003497 | DISPOSABLE PRESSURE MONITOR Engineered Medical Systems | CAP |
| May 26, 2000 | K000215 | SWIVEL ELBOW Engineered Medical Systems | BZD |
| Apr 12, 2000 | K000314 | INCENTIVE SPIROMETER Engineered Medical Systems | BWF |
| Jul 6, 1999 | K991955 | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION Engineered Medical Systems | BTM |
| Jul 1, 1999 | K991953 | MODIFICATION TO ENGINEERED MEDICAL SYSTEMS DISPOSABLE MANUAL RESUSCITATOR WITH CO2 DETECTION Engineered Medical Systems | BTM |
| Apr 7, 1999 | K983919 | EMS MOUTH TO MASK RESUSCITATORS Engineered Medical Systems | CBP |
| Jan 22, 1999 | K983920 | EMS PEEP VALVES- ADJUSTABLE Engineered Medical Systems | BYE |
| Jan 28, 1998 | K972605 | EMS NASAL CPAP MASK Engineered Medical Systems | BZD |
| Sep 3, 1993 | K932799 | SINGLE USE MANUAL RESUSCITATOR PEEP VALVE Engineered Medical Systems | BYE |
| Sep 3, 1993 | K932797 | PRESSURE LIMITING ELBOW Engineered Medical Systems | BTM |
| Apr 21, 1993 | K930083 | EMS BIOPSY INSTRUMENT Engineered Medical Systems | KNW |
| Apr 21, 1993 | K924671 | BAXTER ADULT/PEDI INFANT SINGLE/USE MAN RESUSCIT Engineered Medical Systems | BTM |
| Apr 6, 1993 | K924610 | BAXTER ADULT/PEDI/INFANT SINGLE USE MAN RESUSCIT Engineered Medical Systems | BTM |
| Nov 13, 1991 | K912203 | EMS SINGLE USE MANUAL RESUSCITATORS Engineered Medical Systems | BTM |
| Oct 23, 1991 | K913014 | EMS PERCUSSOR Engineered Medical Systems | BYI |
| Dec 21, 1987 | K874746 | SEALFLEX MASK Engineered Medical Systems | BSJ |
| Jun 8, 1987 | K871851 | RIBBED CUSHION MASK Engineered Medical Systems | BSJ |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 10, 2013 | Engineered Medical Systems,Inc Respironics SealFlex Single Port Ribbed Mask (Infant).
For general use in respiratory and anesthesia applications as a conduit for various gases to resuscitate or to enhance breathing abilities of th Terminated |
BSJ | K874746 |