Salter Labs Neonatal Nasal Oxygen Cannula
FDA 510(k) K911740 · Salter Labs
510(k) numberK911740
Submission
- Device name
- Salter Labs Neonatal Nasal Oxygen Cannula
- Applicant
- Salter Labs
Arvin, CA, US - Received
- April 17, 1991
- Decision date
- July 24, 1991
- 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 |
| 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 |
|---|---|---|
| K261389 | PRO2 Elite Plus Oxygen Analyzer (PRO2PLUS-1)CCL · Traditional | 07/30/2026SE |
| K190878 | Trach- Vac Endotracheal Tube (SFTVPU) Subglottic Suction Tube with Salter Flex-Tip and…BTR · Traditional | 01/10/2020SE |
| K161719 | Salter Labs Bubble HumidifierBTT · Traditional | 09/21/2017SE |
| K151874 | BiNAPS Nasal Airflow and Snore Transducer; ThermiSense Oral/Nasal Thermal AirFlow Sensor…MNR · Traditional | 04/15/2016SE |
| K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaNFB · Traditional | 03/11/2016SE |
| K151421 | Nasal CO2 Sample Line, Oral Nasal CO2 Sampling Cannula, O2 Oral/Nasal Co2 Cannula…CCK · Traditional | 03/10/2016SE |
| K143700 | CPAP CannulaideBZD · Traditional | 08/05/2015SE |
| K142416 | Luma WrapPDH · Traditional | 06/12/2015SE |
| K092685 | Pneumotherml, Model: 5800BZQ · Special | 11/24/2009SE |
| K051313 | Bi-Naps Nasal Airflow and Snore TransducerMNR · Traditional | 09/15/2005SE |
Questions and answers
When was Salter Labs Neonatal Nasal Oxygen Cannula cleared by the FDA?
Salter Labs Neonatal Nasal Oxygen Cannula (K911740) received a 510(k) decision of Substantially Equivalent on July 24, 1991, 98 days after the submission was received.
What is the product code of K911740?
The FDA product code is CAT – Cannula, Nasal, Oxygen, a Class I (low risk) device regulated under 21 CFR 868.5340.