Connector Adapters

FDA 510(k) K810361 · Todd Industries, Inc.

Substantially Equivalent

510(k) numberK810361

Submission

Device name
Connector Adapters
Applicant
Todd Industries, Inc.
Mchenry, IL, US
Received
February 11, 1981
Decision date
March 17, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BZA – Connector, Airway (Extension)
Device class
Class I (low risk)
Regulation
21 CFR 868.5810
Specialty
Anesthesiology

Other 510(k)s with product code BZA

510(k)DeviceApplicantDecision
K083702Trach-AssistBZA · Traditional Mergenet Medical03/05/2009SE
K954383Sureloc Circuit ConnectorBZA · Traditional Polamedco, Inc.12/22/1995SE
K954197Disposable Flex TubeBZA · Traditional Engstrom Medical10/26/1995SE
K953786Unicor, Inc. Connectors & Airway ExtensionsBZA · Traditional Unicor, Inc.09/19/1995SE
K952824Neo-Link, Disposable Neonatal Air Way ConnectorBZA · Traditional Intertex Medical, Inc.07/20/1995SE
K951345Disposable Airway Connectors for Gas SamplingBZA · Traditional Catheter Research, Inc.04/14/1995SE
K944532Prima, Inc. Ventilator HosesBZA · Traditional Prima, Inc.12/02/1994SE
K944535Prima, Inc. Gas Sampling Lines and ConnectorsBZA · Traditional Prima, Inc.11/29/1994SE
K944534Prima, Inc. Connectors and Airway ExtensionsBZA · Traditional Prima, Inc.11/29/1994SE
K942392Airway Connector with Flex TubeBZA · Traditional Mallinckrodt Medical08/22/1994SE

More from Mallinckrodt Medical

510(k)DeviceDecision
K810373Venturi Mask/Delivery System #'SBYF · Traditional 03/17/1981SE
K810362Corrugated Flex TubingBYX · Traditional 03/17/1981SE
K810344Oxygen TubingBYX · Traditional 03/17/1981SE
K810343NebulizersCCQ · Traditional 03/17/1981SE
K810342Nasal CannulaCAT · Traditional 03/17/1981SE
K810341Lifeline Ippb Set-UpBZO · Traditional 03/17/1981SE
K810340Adult Masks & Pediatric MasksBYG · Traditional 03/17/1981SE
K810339Noseclip #6118BXJ · Traditional 03/17/1981SE
K810430Venturi Mask/Delivery System #6078BYF · Traditional 03/13/1981SE
K810374Corrugated Flex Tubing #6000,BYX · Traditional 03/13/1981SE

Questions and answers

When was Connector Adapters cleared by the FDA?

Connector Adapters (K810361) received a 510(k) decision of Substantially Equivalent on March 17, 1981, 34 days after the submission was received.

What is the product code of K810361?

The FDA product code is BZA – Connector, Airway (Extension), a Class I (low risk) device regulated under 21 CFR 868.5810.