The Comfortable Cannula
FDA 510(k) K896036 · Comfortable Concepts Corp.
510(k) numberK896036
Submission
- Device name
- The Comfortable Cannula
- Applicant
- Comfortable Concepts Corp.
Copiague, NY, US - Received
- October 17, 1989
- Decision date
- November 17, 1989
- 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 |
| K892435 | Kendall Curity Oxygen Nasal CannulaCAT · Traditional | The Kendal Co. | 06/12/1989SE |
Questions and answers
When was The Comfortable Cannula cleared by the FDA?
The Comfortable Cannula (K896036) received a 510(k) decision of Substantially Equivalent on November 17, 1989, 31 days after the submission was received.
What is the product code of K896036?
The FDA product code is CAT – Cannula, Nasal, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5340.