Engineered Medical Systems
Medical device manufacturer in Indianapolis, IN.
24510(k) clearances
0PMA approvals
1recalls
Device types
- BTM Ventilator, Emergency, Manual (Resuscitator) 6
- BZD Ventilator, Non-Continuous (Respirator) 3
- BSJ Mask, Gas, Anesthetic 2
- BYE Attachment, Breathing, Positive End… 2
- CAH Filter, Bacterial, Breathing-Circuit 2
- BYI Percussor, Powered-Electric 1
- KNW Instrument, Biopsy 1
- CBP Valve, Non-Rebreathing 1
- BWF Spirometer, Therapeutic (Incentive) 1
- CAP Monitor, Airway Pressure (Includes Gauge… 1
- BZG Spirometer, Diagnostic 1
- JOH Tube Tracheostomy And Tube Cuff 1
- BTO Tube, Tracheostomy (W/Wo Connector) 1
- CCK Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase 1
510(k) clearances
| 510(k) | Device | Decision |
|---|---|---|
| K220533 | Endoscopy Oxygen MaskCCK · Traditional | 11/16/2022SE |
| K062104 | Talking TrachBTO · Traditional | 04/20/2007SE |
| K023683 | Multi-Strap Full Face MaskBZD · Traditional | 12/01/2003SE |
| K013728 | Trach VoxJOH · Traditional | 07/30/2002SE |
| K013122 | EMS Electrostatic Fliter and Hme CombinationCAH · Traditional | 04/19/2002SE |
| K013123 | EMS Pulmonary Function Testing FilterBZG · Traditional | 03/14/2002SE |
| K013089 | EMS Hepa Filter and Hme CombinationsCAH · Traditional | 03/14/2002SE |
| K003497 | Disposable Pressure MonitorCAP · Traditional | 11/30/2000SE |
| K000215 | Swivel ElbowBZD · Traditional | 05/26/2000SE |
| K000314 | Incentive SpirometerBWF · Traditional | 04/12/2000SE |
| K991955 | Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…BTM · Traditional | 07/06/1999SE |
| K991953 | Modification to Engineered Medical Systems Disposable Manual Resuscitator with CO2…BTM · Traditional | 07/01/1999SE |
| K983919 | EMS Mouth to Mask ResuscitatorsCBP · Traditional | 04/07/1999SE |
| K983920 | EMS Peep Valves- AdjustableBYE · Traditional | 01/22/1999SE |
| K972605 | EMS Nasal CPAP MaskBZD · Traditional | 01/28/1998SE |
| K932799 | Single Use Manual Resuscitator Peep ValveBYE · Traditional | 09/03/1993SE |
| K932797 | Pressure Limiting ElbowBTM · Traditional | 09/03/1993SE |
| K930083 | EMS Biopsy InstrumentKNW · Traditional | 04/21/1993SE |
| K924671 | Baxter Adult/Pedi Infant Single/Use Man ResuscitBTM · Traditional | 04/21/1993SE |
| K924610 | Baxter Adult/Pedi/Infant Single Use Man ResuscitBTM · Traditional | 04/06/1993SE |
| K912203 | EMS Single Use Manual ResuscitatorsBTM · Traditional | 11/13/1991SE |
| K913014 | EMS PercussorBYI · Traditional | 10/23/1991SE |
| K874746 | Sealflex MaskBSJ · Traditional | 12/21/1987SE |
| K871851 | Ribbed Cushion MaskBSJ · Traditional | 06/08/1987SE |
Recalls
| Recall | Product | Initiated |
|---|---|---|
| Z-1058-2013 Class I | Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory…The mask inside the package has been identified as "Neonatal" in size and not "Infant" as the labeling… | 09/12/2011Terminated |