Anesthesia Shutoff Valve Positive Closure
FDA 510(k) K854573 · Artec Environmental Monitoring Division
510(k) numberK854573
Submission
- Device name
- Anesthesia Shutoff Valve Positive Closure
- Applicant
- Artec Environmental Monitoring Division
Noblesville, IN, US - Received
- November 14, 1985
- Decision date
- January 3, 1986
- 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 |
|---|---|---|
| K900839 | The Carolina RockerKNN · Traditional | 04/18/1990SE |
| K896886 | Artec Respond Pulmonary ResuscitatorBTM · Traditional | 02/06/1990SE |
| K873043 | Mouth to Face ResuscitatorBTM · Traditional | 09/28/1987SE |
| K863910 | RaincoatBZO · Traditional | 10/20/1986SE |
| K832512 | Airway MasksCAE · Traditional | 01/17/1984SE |
| K830056 | Artec Twist ValveBTC · Traditional | 03/09/1983SE |
Questions and answers
When was Anesthesia Shutoff Valve Positive Closure cleared by the FDA?
Anesthesia Shutoff Valve Positive Closure (K854573) received a 510(k) decision of Substantially Equivalent on January 3, 1986, 50 days after the submission was received.
What is the product code of K854573?
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.