CPAP Cannulaide
FDA 510(k) K143700 · Salter Labs
510(k) numberK143700
Submission
- Device name
- CPAP Cannulaide
- Applicant
- Salter Labs
Carlsbad, CA, US - Received
- December 24, 2014
- Decision date
- August 5, 2015
- 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
Other 510(k)s with product code BZD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253044 | RXiBreeze PAP System (RXiBreeze 20C)BZD · Traditional | Resvent Medical Technology Co., Ltd. | 07/23/2026SE |
| K253553 | OrionBZD · Traditional | Resmed Corp | 06/04/2026SE |
| K254104 | ResScan EssentialsBZD · Traditional | Resmed Corp | 05/27/2026SE |
| K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face…BZD · Traditional | Dcstar, Inc. | 05/21/2026SE |
| K253166 | F6S Full Face Mask (F6S); P6S Nasal Pillows Interface (P6S)BZD · Traditional | BMC Medical Co., Ltd. | 04/29/2026SE |
| 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 |
| K251657 | Personalized Therapy Comfort Settings (PTCS)BZD · Traditional | Resmed Corp | 12/05/2025SE |
More from Resmed Corp
| 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 |
| 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 |
| K040202 | Salter Labs CPAP High Flow Cannula SystemBZD · Traditional | 03/04/2005SE |
Questions and answers
When was CPAP Cannulaide cleared by the FDA?
CPAP Cannulaide (K143700) received a 510(k) decision of Substantially Equivalent on August 5, 2015, 224 days after the submission was received.
What is the product code of K143700?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.