Disposable Anesthesia Breathing Circuit
FDA 510(k) K910896 · Specialty Packaging Producs, Inc.
510(k) numberK910896
Submission
- Device name
- Disposable Anesthesia Breathing Circuit
- Applicant
- Specialty Packaging Producs, Inc.
El Paso, TX, US - Received
- March 4, 1991
- Decision date
- May 8, 1991
- 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 |
|---|---|---|
| K922492 | Specialty Packaging Prod Bacterial/Viral FilterCAH · Traditional | 08/24/1992SE |
| K913163 | Non Rebreathing ValveCBP · Traditional | 02/03/1992SE |
| K913422 | Oxygen Tubing, 81503BYX · Traditional | 01/30/1992SE |
| K913216 | Trach T AdapterBZA · Traditional | 01/15/1992SE |
| K913164 | Non Rebreathing MaskKGB · Traditional | 01/15/1992SE |
| K913421 | Nasal Oxygen Cannula, 81585, 81587 & 81589CAT · Traditional | 10/18/1991SE |
| K913383 | Oxygen Masks 81420, 81421, 81471 & 81461BYG · Traditional | 10/18/1991SE |
| K913275 | Venturi Oxygen MaskBYG · Traditional | 10/10/1991SE |
| K913220 | Aerosol Masks, 81426, 81476, 81490 & 81492CAF · Traditional | 10/10/1991SE |
| K913455 | Oxygen Masks 82400 & 82405BYG · Traditional | 10/02/1991SE |
Questions and answers
When was Disposable Anesthesia Breathing Circuit cleared by the FDA?
Disposable Anesthesia Breathing Circuit (K910896) received a 510(k) decision of Substantially Equivalent on May 8, 1991, 65 days after the submission was received.
What is the product code of K910896?
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.