3B Resmart CPAP and Auto CPAP, BMC Resmart CPAP and Auto CPAP
FDA 510(k) K132967 · 3B Medical, Inc.
510(k) numberK132967
Submission
- Device name
- 3B Resmart CPAP and Auto CPAP, BMC Resmart CPAP and Auto CPAP
- Applicant
- 3B Medical, Inc.
Lake Wales, FL, US - Received
- September 20, 2013
- Decision date
- December 6, 2013
- 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
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| 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 |
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More from Resmed Corp
| 510(k) | Device | Decision |
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| K212263 | Luna G3 BPAP SystemBZD · Traditional | 03/25/2022SE |
| K201620 | Luna® G3 BPAP 25ABZD · Traditional | 01/29/2021SE |
| K200496 | Aer XCAW · Special | 07/24/2020SE |
| K160127 | iCodeConnectBZD · Traditional | 11/10/2016SE |
| K153387 | Luna CPAP and Auto CPAP SystemBZD · Traditional | 09/08/2016SE |
| K141770 | Luna CPAP and Auto-Cpap SystemBZD · Traditional | 04/22/2015SE |
| K133769 | 3B Resmart Bpap 25A, BMC Resmart Bpap 25ABZD · Traditional | 08/25/2014SE |
| K131901 | Ivolve Nasal Mask, Ivolve Full Face Mask, Ivolve N2BZD · Traditional | 12/23/2013SE |
| K131707 | 3B Resmart CPAP and Auto CPAP Systems, BMC Resmart CPAP and Auto CPAP SystemsBZD · Special | 08/22/2013SE |
Questions and answers
When was 3B Resmart CPAP and Auto CPAP, BMC Resmart CPAP and Auto CPAP cleared by the FDA?
3B Resmart CPAP and Auto CPAP, BMC Resmart CPAP and Auto CPAP (K132967) received a 510(k) decision of Substantially Equivalent on December 6, 2013, 77 days after the submission was received.
What is the product code of K132967?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.