Modification to: Sipap Infant Nasal CPAP Circuit
FDA 510(k) K012034 · Sensor Medics Corp.
510(k) numberK012034
Submission
- Device name
- Modification to: Sipap Infant Nasal CPAP Circuit
- Applicant
- Sensor Medics Corp.
Yorba Linda, CA, US - Received
- June 29, 2001
- Decision date
- July 24, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 |
|---|---|---|
| K032516 | HIOX80 Aerosol AdapterCAF · Traditional | 03/04/2004SE |
| K031745 | Infant Flow Plus Infant CPAP System with Sipap FunctionBZD · Traditional | 02/13/2004SE |
| K031883 | Lyra Nasal MaskBZD · Traditional | 08/25/2003SE |
| K030943 | Modification to HioxCBP · Traditional | 04/22/2003SE |
| K022192 | Pegasus Nasal CPAP SystemBZD · Traditional | 01/24/2003SE |
| K020665 | Hi-OxCBP · Traditional | 07/30/2002SE |
| K012085 | Somno Star & Series Sleep SystemOLV · Special | 08/02/2001SE |
| K991972 | Infant Flow SystemBZD · Special | 08/13/1999SE |
| K984254 | Infant Flow Ncpap MasksBZD · Traditional | 02/24/1999SE |
| K981366 | Static and Dynamic Compliance, a Respiratory Mechanics Option for the Vmax SeriesBTY · Traditional | 10/30/1998SE |
Questions and answers
When was Modification to: Sipap Infant Nasal CPAP Circuit cleared by the FDA?
Modification to: Sipap Infant Nasal CPAP Circuit (K012034) received a 510(k) decision of Substantially Equivalent on July 24, 2001, 25 days after the submission was received.
What is the product code of K012034?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.