Adult Temperature Monitoring Anesthesia Circuits
FDA 510(k) K932575 · Med-Plastics Intl., Inc.
510(k) numberK932575
Submission
- Device name
- Adult Temperature Monitoring Anesthesia Circuits
- Applicant
- Med-Plastics Intl., Inc.
Indianapolis, IN, US - Received
- May 27, 1993
- Decision date
- July 22, 1993
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CAI – Circuit, Breathing (W Connector, Adaptor, Y Piece)
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5240
- Specialty
- Anesthesiology
Other 510(k)s with product code CAI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K954480 | Condensate Collection KitCAI · Traditional | Nova-Ventrx | 12/29/1995SE |
| K953788 | Unicor, Inc. Gas Sampling Lines & ConnectorsCAI · Traditional | Unicor, Inc. | 09/19/1995SE |
| K953787 | Unicor, Inc. Adult Anesthesia Breathing CircuitCAI · Traditional | Unicor, Inc. | 09/19/1995SE |
| K952020 | Prima Pediatric Anesthesia CircuitsCAI · Traditional | Prima, Inc. | 05/22/1995SE |
| K952019 | Prima Adult Gas Sampling CircuitsCAI · Traditional | Prima, Inc. | 05/22/1995SE |
| K952018 | Prima Coaxial CircuitsCAI · Traditional | Prima, Inc. | 05/22/1995SE |
| K952017 | Prima Mapleson D CircuitCAI · Traditional | Prima, Inc. | 05/22/1995SE |
| K952016 | Prima Pediatric Gas Sampling CircuitsCAI · Traditional | Prima, Inc. | 05/22/1995SE |
| K952014 | Prima Adult Temperature Monitoring Anesthesia CircuitsCAI · Traditional | Prima, Inc. | 05/22/1995SE |
| K952009 | Prima Pediatric Temperature Monitoring CircuitsCAI · Traditional | Prima, Inc. | 05/19/1995SE |
More from Prima, Inc.
| 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 Adult Temperature Monitoring Anesthesia Circuits cleared by the FDA?
Adult Temperature Monitoring Anesthesia Circuits (K932575) received a 510(k) decision of Substantially Equivalent on July 22, 1993, 56 days after the submission was received.
What is the product code of K932575?
The FDA product code is CAI – Circuit, Breathing (W Connector, Adaptor, Y Piece), a Class I (low risk) device regulated under 21 CFR 868.5240.