Breeze Sleepgear with Dreamseal
FDA 510(k) K002001 · Puritan Bennett Corp.
510(k) numberK002001
Submission
- Device name
- Breeze Sleepgear with Dreamseal
- Applicant
- Puritan Bennett Corp.
Minneapolis, MN, US - Received
- June 30, 2000
- Decision date
- September 6, 2000
- 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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| 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 |
|---|---|---|
| K063650 | Ventilator with Respiratory Mechanics, Model 840CBK · Special | 02/15/2007SE |
| K053388 | Model 840 Ventilator with Proportional Assist Ventilation Plus Software OptionCBK · Traditional | 04/04/2006SE |
| K023225 | Puritan Bennett Dataflow Data Management SoftwareBZG · Abbreviated | 12/18/2002SE |
| K022103 | Puritan-Bennett 700 Renaissance II Spirometry SystemBZG · Special | 09/27/2002SE |
| K021573 | Puritan-Bennett 840 Ventilatior System with Volume Ventilation Plus OptionCBK · Special | 08/13/2002ST |
| K001646 | Puritan-Bennett 840 Ventilator System with Neomode OptionCBK · Traditional | 10/20/2000ST |
| K993071 | Puritan-Bennett Ventilator System with Et/Tracheostomy Tube Compensation, TC, Option…CBK · Special | 11/24/1999ST |
| K993220 | Puritan-Bennett Helios Portable Liquid Oxygen SystemBYJ · Special | 10/22/1999SE |
| K993088 | Puritan-Bennett Aeris 590 Oxygen Concentrator with OciCAW · Special | 10/08/1999SE |
| K984535 | Puritan-Bennett 840 Ventilatory System with Bilevel OptionCBK · Special | 12/28/1998ST |
Questions and answers
When was Breeze Sleepgear with Dreamseal cleared by the FDA?
Breeze Sleepgear with Dreamseal (K002001) received a 510(k) decision of Substantially Equivalent on September 6, 2000, 68 days after the submission was received.
What is the product code of K002001?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.