Salter Labs CPAP High Flow Cannula System
FDA 510(k) K040202 · Salter Labs
510(k) numberK040202
Submission
- Device name
- Salter Labs CPAP High Flow Cannula System
- Applicant
- Salter Labs
Arvin, CA, US - Received
- January 29, 2004
- Decision date
- March 4, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZD – Ventilator, Non-Continuous (Respirator)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5905
- Specialty
- Anesthesiology
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| K254104 | ResScan EssentialsBZD · Traditional | Resmed Corp | 05/27/2026SE |
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| K252338 | MySleepDashBZD · Traditional | Somnetics International, Inc. (Dba Transcend Inc) | 04/17/2026SE |
| K251847 | Sleepnet Arie Full Face Vented Mask; Sleepnet Arie Nasal Vented MaskBZD · Traditional | Sleepnet Corporation | 01/15/2026SE |
| K253939 | DeltaWave Nasal Pillow SystemBZD · Special | RemSleep Holdings, Inc. | 01/07/2026SE |
| K251770 | SleepRes PAP SystemBZD · Traditional | Sleepres, Inc. | 12/15/2025SE |
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| 510(k) | Device | Decision |
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| 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 CPAP High Flow Cannula System cleared by the FDA?
Salter Labs CPAP High Flow Cannula System (K040202) received a 510(k) decision of Substantially Equivalent on March 4, 2005, 400 days after the submission was received.
What is the product code of K040202?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.