Skin Saver(Tm) Tubing Holder, Model 1921 Modified
FDA 510(k) K921496 · Alpine Specialties, Inc.
510(k) numberK921496
Submission
- Device name
- Skin Saver(Tm) Tubing Holder, Model 1921 Modified
- Applicant
- Alpine Specialties, Inc.
Loveland, CO, US - Received
- March 9, 1992
- Decision date
- August 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
| 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 |
| K892435 | Kendall Curity Oxygen Nasal CannulaCAT · Traditional | The Kendal Co. | 06/12/1989SE |
More from The Kendal Co.
| 510(k) | Device | Decision |
|---|---|---|
| K912197 | Skin Saver(Tm) Tubing Holder, Model 467CAT · Traditional | 08/20/1991SE |
Questions and answers
When was Skin Saver(Tm) Tubing Holder, Model 1921 Modified cleared by the FDA?
Skin Saver(Tm) Tubing Holder, Model 1921 Modified (K921496) received a 510(k) decision of Substantially Equivalent on August 14, 1992, 158 days after the submission was received.
What is the product code of K921496?
The FDA product code is CAT – Cannula, Nasal, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5340.