Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula Manufactured by Hrci
FDA 510(k) K011125 · Hudson Respiratory Care, Inc.
510(k) numberK011125
Submission
- Device name
- Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula Manufactured by Hrci
- Applicant
- Hudson Respiratory Care, Inc.
Temecula, CA, US - Received
- April 13, 2001
- Decision date
- June 13, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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 |
|---|---|---|---|
| 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 |
| K892435 | Kendall Curity Oxygen Nasal CannulaCAT · Traditional | The Kendal Co. | 06/12/1989SE |
More from The Kendal Co.
| 510(k) | Device | Decision |
|---|---|---|
| K031383 | Model 780BTT · Special | 07/07/2003SE |
| K011134 | Oxygen Supply Tubing, Model 1115BYX · Traditional | 06/13/2001SE |
| K010402 | Smooth-Flo CircuitBTT · Special | 03/14/2001SE |
| K001213 | Conchatherm 2000 Humidification System, Models 500-00, -10, -20, -30, -40, -50, & -60BTT · Traditional | 11/03/2000SE |
| K993355 | Hudson Rci Concha Column, Cat. No. 385-40 and Hudson Rci Circuit, Cat. No. 780-40…BTT · Traditional | 05/24/2000SE |
| K994352 | Side Draft Neb-U-Mist Nebulizer, Model 41896CAF · Traditional | 03/22/2000SE |
| K964719 | Hudson Rci Lifesaver Single Patient Use Manual ResuscitatorBTM · Traditional | 02/21/1997SE |
| K961150 | Dual Lumen Oxygen Delivery Gas Sampling CannulaCCK · Traditional | 09/10/1996SE |
| K961914 | Bacteria/Viral FilterCAH · Traditional | 08/14/1996SE |
| K955645 | Cath-GuideBSY · Traditional | 03/12/1996SE |
Questions and answers
When was Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula Manufactured by Hrci cleared by the FDA?
Nasal Cannula, with and Without Supply Tubing, and Other Similar Nasal Cannula Manufactured by Hrci (K011125) received a 510(k) decision of Substantially Equivalent on June 13, 2001, 61 days after the submission was received.
What is the product code of K011125?
The FDA product code is CAT – Cannula, Nasal, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5340.