Pediatric Anesthesia Circuit
FDA 510(k) K770549 · Inspiron Corp.
510(k) numberK770549
Submission
- Device name
- Pediatric Anesthesia Circuit
- Applicant
- Inspiron Corp.
Mchenry, IL, US - Received
- March 21, 1977
- Decision date
- March 30, 1977
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
|---|---|---|
| K860838 | Inspiron Double Swivel Trach AdapterBZA · Traditional | 04/09/1986SE |
| K850346 | Oxygen ConcentratorCAW · Traditional | 02/04/1985SE |
| K843932 | Vapor-Phase Humidifier Sys-AdvancedBTT · Traditional | 10/18/1984SE |
| K840935 | Manual Resuscitation SystemBTM · Traditional | 04/05/1984SE |
| K841158 | Nebulo 28 Nebulizer KitBTT · Traditional | 03/30/1984SE |
| K840418 | Inspiratory/Expiratory Muscle ExercisBWF · Traditional | 02/17/1984SE |
| K834290 | Inspiron Liquid Oxygen SystemBYJ · Traditional | 02/04/1984SE |
| K772072 | Manifold & Nebu. for Doub. Line Mach.CAF · Traditional | 11/15/1977SE |
| K772071 | Manifold & Nebu. for Single Line Mach.CAF · Traditional | 11/15/1977SE |
| K772070 | Ventilator Setup, VolumeCAF · Traditional | 11/15/1977SE |
Questions and answers
When was Pediatric Anesthesia Circuit cleared by the FDA?
Pediatric Anesthesia Circuit (K770549) received a 510(k) decision of Substantially Equivalent on March 30, 1977, 9 days after the submission was received.
What is the product code of K770549?
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.