# Engineered Medical Systems

- Location (FDA's records): Indianapolis, IN
- FDA decisions: 24 (1987–2022): 24 510(k) clearances
- Names in FDA's records: Engineered Medical Systems (22); Engineered Medical Systems, Inc. (2)
- Product codes: BTM (6), BZD (3), BSJ (2), CAH (2), BYE (2), BTO (1), BZG (1), JOH (1), BWF (1), KNW (1), BYI (1), CAP (1)
- Predicates its devices cite: 38 (5 its own); citations of its devices by later devices: 24 (5 its own)
- Recalls linked to its devices: 2 (1 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Mallinckrodt Medical: 6 (https://510kreport.com/company/mallinckrodt-medical)
- Respironics, Inc.: 2 (https://510kreport.com/company/respironics)
- Passy-Muir, Inc.: 2 (https://510kreport.com/company/passy-muir)
- Sims Portex, Inc.: 2 (https://510kreport.com/company/sims-portex)
- Nellcor Puritan Bennett, Inc.: 2 (https://510kreport.com/company/nellcor-puritan-bennett)
- Fenem, Inc.: 2 (https://510kreport.com/company/fenem)
- Nellcor, Inc.: 2 (https://510kreport.com/company/nellcor)
- Caradyne, Ltd.: 1 (https://510kreport.com/company/caradyne)

## Firms that cite its devices most
- Air Safety, Ltd.: 4 (https://510kreport.com/company/air-safety)
- Vital Signs, Inc.: 1 (https://510kreport.com/company/vital-signs)
- Westmed, Inc.: 1 (https://510kreport.com/company/westmed)
- Datex-Ohmeda, Inc.: 1 (https://510kreport.com/company/datex-ohmeda)
- Urological, Inc.: 1 (https://510kreport.com/company/urological)
- Vr Medical: 1 (https://510kreport.com/company/vr-medical)
- Pulmonary Filtration Technologies, LLC: 1 (https://510kreport.com/company/pulmonary-filtration-technologies)
- Hsiner Co., Ltd.: 1 (https://510kreport.com/company/hsiner)

## Its most-cited devices
- K013089: Ems Hepa Filter and Hme Combinations (2002), cited by 5
- K003497: Disposable Pressure Monitor (2000), cited by 4
- K924610: Baxter Adult/Pedi/Infant Single Use Man Resuscit (1993), cited by 3
- K013123: Ems Pulmonary Function Testing Filter (2002), cited by 2
- K983920: Ems Peep Valves- Adjustable (1999), cited by 2
- K013122: Ems Electrostatic Fliter and Hme Combination (2002), cited by 2

## Recent decisions
- K220533: Endoscopy Oxygen Mask (Nov 16, 2022)
- K062104: Talking Trach (Apr 20, 2007)
- K023683: Multi-Strap Full Face Mask (Dec 1, 2003)
- K013728: Trach Vox (Jul 30, 2002)
- K013122: Ems Electrostatic Fliter and Hme Combination (Apr 19, 2002)
- K013089: Ems Hepa Filter and Hme Combinations (Mar 14, 2002)
- K013123: Ems Pulmonary Function Testing Filter (Mar 14, 2002)
- K003497: Disposable Pressure Monitor (Nov 30, 2000)

Source page: https://510kreport.com/company/engineered-medical-systems