510(k) Report

FDA applicant

Engineered Medical Systems

Indianapolis, IN24 decisions1987–20222 recalls

FDA records 24 decisions for Engineered Medical Systems (Indianapolis, IN) from 1987 to 2022: 24 510(k) clearances. Most are in product codes BTM (Ventilator, Emergency, Manual (Resuscitator)) and BZD (Ventilator, Non-Continuous (Respirator)). Its devices cite 38 predicates, 5 of them its own earlier devices. 2 recalls are linked to its devices, 1 Class I.

FDA’s records also spell it “Engineered Medical Systems, Inc.”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, anesthesiology panel, where it files most

How often FDA has decided Engineered Medical Systems’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2007: 12022: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

1in 2013

2011: 1, 1 Class I2013: 1
2007high 1 (2011) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Engineered Medical Systems by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Engineered Medical Systems’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • BTMVentilator, Emergency, Manual (Resuscitator)6decisions
  • BZDVentilator, Non-Continuous (Respirator)3decisions
  • BSJMask, Gas, Anesthetic2decisions
  • CAHFilter, Bacterial, Breathing-Circuit2decisions
  • BYEAttachment, Breathing, Positive End Expiratory Pressure2decisions
  • BTOTube, Tracheostomy (W/Wo Connector)1decision

Also: BZG (1), JOH (1), BWF (1), KNW (1), BYI (1), CAP (1).

Whose devices does it build on?

Its devices cite 38 predicates; 5 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 24 times; 5 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K013089Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 20025cite it
  • K003497Disposable Pressure MonitorEngineered Medical Systems · 20004cite it
  • K924610Baxter Adult/Pedi/Infant Single Use Man ResuscitEngineered Medical Systems · 19933cite it
  • K013123Ems Pulmonary Function Testing FilterEngineered Medical Systems · 20022cite it
  • K983920Ems Peep Valves- AdjustableEngineered Medical Systems · 19992cite it
  • K013122Ems Electrostatic Fliter and Hme CombinationEngineered Medical Systems · 20022cite it

What has FDA decided for it lately?

  • K220533Endoscopy Oxygen MaskEngineered Medical Systems, Inc. · 2022
  • K062104Talking TrachEngineered Medical Systems, Inc. · 2007
  • K023683Multi-Strap Full Face MaskEngineered Medical Systems · 2003
  • K013728Trach VoxEngineered Medical Systems · 2002
  • K013122Ems Electrostatic Fliter and Hme CombinationEngineered Medical Systems · 2002
  • K013089Ems Hepa Filter and Hme CombinationsEngineered Medical Systems · 2002
  • K013123Ems Pulmonary Function Testing FilterEngineered Medical Systems · 2002
  • K003497Disposable Pressure MonitorEngineered Medical Systems · 2000

All 22 as Engineered Medical Systems →All 2 as Engineered Medical Systems, Inc. →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K9246101) Adult Manual Resuscitator, 2K8004, Oxygen Reservoir Bag, Adult Mask; 2) Adult Manual…Apr 22, 2013Class II
  • K874746Respironics SealFlex Single Port Ribbed Mask (Infant). For general use in respiratory…Sep 12, 2011Class I

Other applicant names beginning “Engineered”

FDA records each applicant name separately; these may or may not be the same firm.

Engineered Medical Solutions Co., LLC 2Engineered Orthopedic Technologies, Inc. 2Engineered Medical Technology, Inc. 1Engineered Tissue Solutions, LLC 1Engineered Endodontics 1Engineered Custom Mfg., Inc. 1