Modified Baromed Breathing Pressure Monitor

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K861720 ↗

FDA Product Code

CAP

Device Class

Class II

Regulation

21 CFR Part 868.2600

Advisory Committee

Anesthesiology

FDA Decision

SESE Substantially Equivalent

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See all devices from Draeger Medical, Inc. →

• Is the Modified Baromed Breathing Pressure Monitor designed for single-use or can it be reused in clinical settings?

  The Modified Baromed Breathing Pressure Monitor is explicitly supplied as a reusable medical instrument. Since it is intended for use in controlled environments like operating rooms or anesthesia suites, it must be properly cleaned, disinfected, and maintained between uses to ensure accuracy and patient safety. Reusability is a key feature for facilities managing inventory and operational workflows.

• What clinical specialties or procedures is this device primarily intended for?

  This device is specifically designed for anesthesiology procedures, where precise monitoring of airway pressure is critical. It is not intended for general patient monitoring outside of controlled clinical environments like operating rooms or anesthesia suites, where airway management is a primary concern.

• How is the Modified Baromed Breathing Pressure Monitor regulated in the U.S., and when was it first authorized?

  The device is regulated under FDA 510(k) clearance (K861720) and falls under Class II classification, indicating it has undergone a premarket review to demonstrate substantial equivalence to a legally marketed predicate device. It was first authorized for commercial distribution in 1986, with its regulatory pathway adhering to 21 CFR 868.2600 for airway pressure monitors.

• Are there multiple models or sizes available for this device, or is it supplied as a single unit?

  The provided data lists multiple registration numbers (e.g., 3013557562, 1000307109, etc.), which typically correspond to different lot numbers or variants of the same device model rather than distinct physical sizes or configurations. However, there is no explicit mention of multiple models or sizes in the description. Facilities should confirm with Draeger Medical, Inc. if specific configurations or accessories are available for their workflow.