Modified Demand Nasal Oxygen Cannula
FDA 510(k) K892407 · Salter Labs
510(k) numberK892407
Submission
- Device name
- Modified Demand Nasal Oxygen Cannula
- Applicant
- Salter Labs
Arvin, CA, US - Received
- April 7, 1989
- Decision date
- July 24, 1989
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- NFB – Conserver, Oxygen
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
Other 510(k)s with product code NFB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250322 | Respond OC Conserving Regulator (130-0800)NFB · Traditional | Responsive Respiratory | 07/24/2025SE |
| K220591 | ProximaNFB · Traditional | Dynasthetics, LLC | 12/15/2022SE |
| K221014 | Effortless Oxygen Conserver System Models Effortless Pro and Effortless MobileNFB · Traditional | Effortless Oxygen, LLC | 10/17/2022SE |
| K200401 | ApogeeNFB · Traditional | Incoba Ltd D/B/A Dynaris | 11/14/2020SE |
| K151506 | Demand Nasal Oxygen Cannula, Modified Demand Nasal Oxygen CannulaNFB · Traditional | Salter Labs | 03/11/2016SE |
| K131023 | Theraflow Single Lumen and Theraflow Dual LumenNFB · Traditional | Medical Products, LLC | 10/11/2013SE |
| K113111 | Chad Therapeutic Evolution Electronic Oxygen Conserver with MotionNFB · Special | Inovo, Inc. | 12/08/2011SE |
| K103392 | Chad Therapeutic Evolution Electronic Oxygen ConserverNFB · Special | Inovo, Inc. | 12/17/2010SE |
| K090421 | Model 350G Gas ConserverNFB · Traditional | Inspired Technologies, Inc. | 05/29/2009SE |
| K070740 | Chad Therapeutics Bonsai Model 800NFB · Special | Chad Therapeutics, Inc. | 05/07/2007SE |
More from Chad Therapeutics, Inc.
| 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 Modified Demand Nasal Oxygen Cannula cleared by the FDA?
Modified Demand Nasal Oxygen Cannula (K892407) received a 510(k) decision of Substantially Equivalent on July 24, 1989, 108 days after the submission was received.
What is the product code of K892407?
The FDA product code is NFB – Conserver, Oxygen, a Class II (moderate risk) device regulated under 21 CFR 868.5905.