Anesthesia Breathing Circuits
FDA 510(k) K900428 · Med-Tek Corp.
510(k) numberK900428
Submission
- Device name
- Anesthesia Breathing Circuits
- Applicant
- Med-Tek Corp.
Glendale, WI, US - Received
- January 30, 1990
- Decision date
- August 17, 1990
- 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 |
|---|---|---|
| K903234 | F-19 Total Hip ProsthesisJDI · Traditional | 10/10/1990SE |
| K901687 | F-24 Femoral Hip ProsthesisLWJ · Traditional | 09/07/1990SE |
| K901451 | F-20 Cemented Metal-Backed Acetabular CupJDI · Traditional | 08/31/1990SN |
| K901626 | H.N. Metal Backed Acetabular Cup, NoncementedKWA · Traditional | 08/14/1990SE |
| K901594 | H.N. Total Hip ProsthesisLWJ · Traditional | 08/03/1990SE |
| K901480 | F-20 Total Hip ProsthesisJDI · Traditional | 06/12/1990SE |
| K901273 | L.M.S. Self-Detachable Broach with StopHTY · Traditional | 06/05/1990SE |
| K901272 | Orion Blade Plate for Tibial OsteotomyKTT · Traditional | 04/23/1990SE |
| K901240 | Astel Non-Metal Backed Acetabular Cup for CementedJDI · Traditional | 03/26/1990SE |
| K894978 | Bacterial FilterCAH · Traditional | 11/02/1989SE |
Questions and answers
When was Anesthesia Breathing Circuits cleared by the FDA?
Anesthesia Breathing Circuits (K900428) received a 510(k) decision of Substantially Equivalent on August 17, 1990, 199 days after the submission was received.
What is the product code of K900428?
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.