Sandman Intro
FDA 510(k) K071575 · Mallinckrodt Developpement France
510(k) numberK071575
Submission
- Device name
- Sandman Intro
- Applicant
- Mallinckrodt Developpement France
Pleasanton, CA, US - Received
- June 8, 2007
- Decision date
- September 10, 2007
- 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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|---|---|---|---|
| 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 |
|---|---|---|
| K082237 | Puritan Bennett, Sandman Duo and Sandman Duo STBZD · Special | 10/09/2008SE |
| K080439 | Sandman Info Without Humidifier/ Sandman Auto Without Humidifier, Model…BZD · Special | 05/16/2008SE |
| K063501 | Knightcontrol Remote Control, Model M-114700-USBZD · Traditional | 04/06/2007SE |
| K042184 | Goodknight H20, Model M-114600-00BTT · Traditional | 01/10/2005SE |
| K041819 | Goodknight 425, MODELM-114500-00BZD · Special | 07/22/2004SE |
| K001845 | Mallinckrodt, Goodknight 418SBZD · Special | 07/05/2000SE |
Questions and answers
When was Sandman Intro cleared by the FDA?
Sandman Intro (K071575) received a 510(k) decision of Substantially Equivalent on September 10, 2007, 94 days after the submission was received.
What is the product code of K071575?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.