Connectors and Airway Extensions
FDA 510(k) K931038 · Med-Plastics Intl., Inc.
510(k) numberK931038
Submission
- Device name
- Connectors and Airway Extensions
- Applicant
- Med-Plastics Intl., Inc.
Indianapolis, IN, US - Received
- March 1, 1993
- Decision date
- April 8, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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) | Device | Applicant | Decision |
|---|---|---|---|
| K083702 | Trach-AssistBZA · Traditional | Mergenet Medical | 03/05/2009SE |
| K954383 | Sureloc Circuit ConnectorBZA · Traditional | Polamedco, Inc. | 12/22/1995SE |
| K954197 | Disposable Flex TubeBZA · Traditional | Engstrom Medical | 10/26/1995SE |
| K953786 | Unicor, Inc. Connectors & Airway ExtensionsBZA · Traditional | Unicor, Inc. | 09/19/1995SE |
| K952824 | Neo-Link, Disposable Neonatal Air Way ConnectorBZA · Traditional | Intertex Medical, Inc. | 07/20/1995SE |
| K951345 | Disposable Airway Connectors for Gas SamplingBZA · Traditional | Catheter Research, Inc. | 04/14/1995SE |
| K944532 | Prima, Inc. Ventilator HosesBZA · Traditional | Prima, Inc. | 12/02/1994SE |
| K944535 | Prima, Inc. Gas Sampling Lines and ConnectorsBZA · Traditional | Prima, Inc. | 11/29/1994SE |
| K944534 | Prima, Inc. Connectors and Airway ExtensionsBZA · Traditional | Prima, Inc. | 11/29/1994SE |
| K942392 | Airway Connector with Flex TubeBZA · Traditional | Mallinckrodt Medical | 08/22/1994SE |
More from Mallinckrodt Medical
| 510(k) | Device | Decision |
|---|---|---|
| K946209 | Dispodable Heat & Moisture Exchanger and Filter/HmeBYD · Traditional | 06/08/1995SE |
| K942572 | Volume VentilatorBZO · Traditional | 06/10/1994SE |
| K942571 | Hyper-Inflation BagNHK · Traditional | 06/10/1994SE |
| K942570 | Mapleson D CircuitCAI · Traditional | 06/10/1994SE |
| K942569 | Ventilator HoseBZO · Traditional | 06/10/1994SE |
| K942568 | Adult Anesthesia Breathing CircuitCAI · Traditional | 06/10/1994SE |
| K942567 | Mass Spectrometry Monitoring Lines and ConnectorsCCK · Traditional | 06/10/1994SE |
| K932578 | Adult Gas Sampling CircuitsCAI · Traditional | 07/22/1993SE |
| K932577 | Pediatric Gas SamplingCAI · Traditional | 07/22/1993SE |
| K932576 | Pediatric Temperature Monitoring CircuitsCAI · Traditional | 07/22/1993SE |
Questions and answers
When was Connectors and Airway Extensions cleared by the FDA?
Connectors and Airway Extensions (K931038) received a 510(k) decision of Substantially Equivalent on April 8, 1993, 38 days after the submission was received.
What is the product code of K931038?
The FDA product code is BZA – Connector, Airway (Extension), a Class I (low risk) device regulated under 21 CFR 868.5810.