Cannulas, Dynacor's Nasal Oxygen
FDA 510(k) K790056 · Medline Industries, Inc.
510(k) numberK790056
Submission
- Device name
- Cannulas, Dynacor's Nasal Oxygen
- Applicant
- Medline Industries, Inc.
Mchenry, IL, US - Received
- January 9, 1979
- Decision date
- February 5, 1979
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- CAT – Cannula, Nasal, Oxygen
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 868.5340
- Specialty
- Anesthesiology
Other 510(k)s with product code CAT
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K011125 | Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula…CAT · Traditional | Hudson Respiratory Care, Inc. | 06/13/2001SE |
| K935533 | Nasal CannulaCAT · Traditional | Puritas Health Care, Inc. | 02/03/1994SE |
| K922397 | 4 Sure TM Nasal Oxygen CannulaCAT · Traditional | Boston Pacific Medical, Inc. | 03/18/1993SE |
| K921496 | Skin Saver(Tm) Tubing Holder, Model 1921 ModifiedCAT · Traditional | Alpine Specialties, Inc. | 08/14/1992SE |
| K920573 | Cannula Nasal OxygenCAT · Traditional | B & F Medical Products, Inc. | 08/11/1992SE |
| K913421 | Nasal Oxygen Cannula, 81585, 81587 & 81589CAT · Traditional | Specialty Packaging Producs, Inc. | 10/18/1991SE |
| K912197 | Skin Saver(Tm) Tubing Holder, Model 467CAT · Traditional | Alpine Specialties, Inc. | 08/20/1991SE |
| K911740 | Salter Labs Neonatal Nasal Oxygen CannulaCAT · Traditional | Salter Labs | 07/24/1991SE |
| K902420 | Catheter, Nasal, OxygenCAT · Traditional | Gainor Medical Europe, Ltd. | 04/17/1991SE |
| K896036 | The Comfortable CannulaCAT · Traditional | Comfortable Concepts Corp. | 11/17/1989SE |
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| K250312 | Hudson RCI® Comfort Flo Nasal Cannula Premature, Infant; Hudson RCI® Comfort Flo Plus…BTT · Traditional | 07/02/2025SE |
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Questions and answers
When was Cannulas, Dynacor's Nasal Oxygen cleared by the FDA?
Cannulas, Dynacor's Nasal Oxygen (K790056) received a 510(k) decision of Substantially Equivalent on February 5, 1979, 27 days after the submission was received.
What is the product code of K790056?
The FDA product code is CAT – Cannula, Nasal, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5340.