Prima Pediatric Gas Sampling Circuits
FDA 510(k) K952016 · Prima, Inc.
510(k) numberK952016
Submission
- Device name
- Prima Pediatric Gas Sampling Circuits
- Applicant
- Prima, Inc.
Cleveland, TN, US - Received
- April 28, 1995
- Decision date
- May 22, 1995
- 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 |
| 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 |
| K945565 | Spiro-FlexCAI · Traditional | Inhalation Plastics | 01/13/1995SE |
More from Inhalation Plastics
| 510(k) | Device | Decision |
|---|---|---|
| K952022 | Prima Volumn VentilatorssBZO · Traditional | 05/22/1995SE |
| K952021 | Prima Hyuperinflation SystemBZR · Traditional | 05/22/1995SE |
| K952020 | Prima Pediatric Anesthesia CircuitsCAI · Traditional | 05/22/1995SE |
| K952019 | Prima Adult Gas Sampling CircuitsCAI · Traditional | 05/22/1995SE |
| K952018 | Prima Coaxial CircuitsCAI · Traditional | 05/22/1995SE |
| K952017 | Prima Mapleson D CircuitCAI · Traditional | 05/22/1995SE |
| K952015 | Prima FilterCAH · Traditional | 05/22/1995SE |
| K952014 | Prima Adult Temperature Monitoring Anesthesia CircuitsCAI · Traditional | 05/22/1995SE |
| K952013 | Prima Guedel AirwaysBTR · Traditional | 05/22/1995SE |
| K952012 | Prima Custom Anestesia CircuitBZO · Traditional | 05/22/1995SE |
Questions and answers
When was Prima Pediatric Gas Sampling Circuits cleared by the FDA?
Prima Pediatric Gas Sampling Circuits (K952016) received a 510(k) decision of Substantially Equivalent on May 22, 1995, 24 days after the submission was received.
What is the product code of K952016?
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.