Oxygen Tubing, 81503
FDA 510(k) K913422 · Specialty Packaging Producs, Inc.
510(k) numberK913422
Submission
- Device name
- Oxygen Tubing, 81503
- Applicant
- Specialty Packaging Producs, Inc.
El Paso, TX, US - Received
- July 31, 1991
- Decision date
- January 30, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BYX – Tubing, Pressure And Accessories
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5860
- Specialty
- Anesthesiology
Other 510(k)s with product code BYX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011134 | Oxygen Supply Tubing, Model 1115BYX · Traditional | Hudson Respiratory Care, Inc. | 06/13/2001SE |
| K955656 | North State Plastics Aerosol TeeBYX · Traditional | North State Plastics, Inc. | 03/06/1996SE |
| K943110 | Gas Sampling InterfacesBYX · Traditional | Coast Medical, Inc. | 08/19/1994SE |
| K935835 | Busse Plastic Tubing Connectors and AccessoriesBYX · Traditional | Busse Hospital Disposables, Inc. | 01/12/1994SE |
| K931043 | MF Ohmeda Style Medical Gas Wall OutletsBYX · Traditional | Medical Fittings, Inc. | 06/01/1993SE |
| K931033 | MF Chemetron Style Medical Gas Wall OutletsBYX · Traditional | Medical Fittings, Inc. | 06/01/1993SE |
| K914980 | Hex, Quad, or Rail Block Manifold AccessoriesBYX · Traditional | Medical Fittings, Inc. | 01/21/1992SE |
| K912763 | Ohmeda Style Check Units (Female Couplers)BYX · Traditional | Medical Fittings, Inc. | 10/15/1991SE |
| K905091 | Various Male Quick Connects.BYX · Traditional | Medical Fittings, Inc. | 03/04/1991SE |
| K905094 | Schrader Oxygen/Air Vac&Nitr-Oxide Male Quick ConnBYX · Traditional | Medical Fittings, Inc. | 11/20/1990SE |
More from Medical Fittings, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K922492 | Specialty Packaging Prod Bacterial/Viral FilterCAH · Traditional | 08/24/1992SE |
| K913163 | Non Rebreathing ValveCBP · Traditional | 02/03/1992SE |
| 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 |
| K910896 | Disposable Anesthesia Breathing CircuitCAI · Traditional | 05/08/1991SE |
Questions and answers
When was Oxygen Tubing, 81503 cleared by the FDA?
Oxygen Tubing, 81503 (K913422) received a 510(k) decision of Substantially Equivalent on January 30, 1992, 183 days after the submission was received.
What is the product code of K913422?
The FDA product code is BYX – Tubing, Pressure And Accessories, a Class I (low risk) device regulated under 21 CFR 868.5860.