Flow Generator for Sleep Apnea, LDS 1500
FDA 510(k) K862448 · Life Design Systems, Inc.
510(k) numberK862448
Submission
- Device name
- Flow Generator for Sleep Apnea, LDS 1500
- Applicant
- Life Design Systems, Inc.
Milwaukee, WI, US - Received
- June 27, 1986
- Decision date
- November 14, 1986
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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 |
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| 510(k) | Device | Decision |
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| K913714 | Modification Manual Pulmon Resuscitor/Pulmanex(Tm)BTM · Traditional | 12/01/1992SE |
| K885313 | Humidi-Flex TMBYD · Traditional | 10/11/1989SE |
| K893030 | Child Size - Filter Flex (TM)CAH · Traditional | 09/18/1989SE |
| K892862 | Flex-Cup PercussorBYI · Traditional | 05/25/1989SE |
| K892221 | Pulmonary Resuscitator, ModificationBTM · Traditional | 05/18/1989SE |
| K890011 | Oxygen Connector and Oxygen Delivery TubingBZO · Traditional | 03/20/1989SE |
| K890108 | Modified Cushion-Flex(Tm)BSJ · Traditional | 01/24/1989SE |
| K884387 | Cushion Flex(Tm)BSJ · Traditional | 11/17/1988SE |
| K884068 | Pulmanex TM (Neo-Natal Size)BTM · Traditional | 11/16/1988SE |
| K873179 | Heater Wire Breathing CircuitBZE · Traditional | 03/31/1988SE |
Questions and answers
When was Flow Generator for Sleep Apnea, LDS 1500 cleared by the FDA?
Flow Generator for Sleep Apnea, LDS 1500 (K862448) received a 510(k) decision of Substantially Equivalent on November 14, 1986, 140 days after the submission was received.
What is the product code of K862448?
The FDA product code is BZD – Ventilator, Non-Continuous (Respirator), a Class II (moderate risk) device regulated under 21 CFR 868.5905.