Nonrebreathing Circuit
by Dryden Corp. 510(k)
Active
510(k) K882285
Overview
A Nonrebreathing Circuit is a ventilator, emergency, manual (resuscitator) device used in anesthesiology. It is designed to deliver oxygen and anesthetic gases to a patient while preventing rebreathing of exhaled gases.
This device is supplied by Dryden Corp. and has received FDA 510(k) clearance under K882285 with product code BTM. It is classified as a Class II medical device and is intended for use in clinical settings requiring manual ventilation support.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK882285 | Date16 Aug 1988 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
Specification
- 510(k) Number
- FDA Product Code
- BTM
- Device Class
- Class II
- Regulation
- 21 CFR Part 868.5915
- Advisory Committee
- Anesthesiology
- FDA Decision
- SESE Substantially Equivalent
Other devices from Dryden Corp.
Questions
What is the Nonrebreathing Circuit used for?
The Nonrebreathing Circuit is used in anesthesiology to deliver oxygen and anesthetic gases to a patient while preventing rebreathing of exhaled gases, providing manual ventilation support in clinical settings such as operating rooms or emergency situations.
How is the Nonrebreathing Circuit supplied and by whom?
The Nonrebreathing Circuit is supplied by Dryden Corp., located at 10640 E. 59th St., P.O. Box 36038, Indianapolis, IN 46236, United States, as indicated in the device registration data.
Is the Nonrebreathing Circuit a single-use or reusable device?
The device data does not specify whether the Nonrebreathing Circuit is single-use or reusable; therefore, no determination can be made about its reusability based solely on the provided information.
What regulatory pathway was used for the Nonrebreathing Circuit?
The Nonrebreathing Circuit received FDA 510(k) clearance under K882285 with product code BTM, following a traditional clearance process and was found substantially equivalent to a predicate device.
What class is the Nonrebreathing Circuit and what product code does it have?
The Nonrebreathing Circuit is classified as a Class II medical device with product code BTM, as indicated in the openfda data and authorization details.