Data / Medical devices / China / Shenzhen Sany Pioneer Technology Co., Ltd.
Shenzhen Sany Pioneer Technology Co., Ltd.: FDA-registered device maker in Shenzhen Guangdong, China, 4 510(k) clearances
Shenzhen Sany Pioneer Technology Co., Ltd. is registered with the FDA (registration 3016674860) in Shenzhen Guangdong, China. It lists 8 device types. The FDA files 4 510(k) clearances under its listings, the newest dated August 27, 2026. Registered through 2027. FDA data exported November 3, 2026.
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- FDA registration number
- 3016674860
- Address
- 503A, 302, No.2 Factory Building, Fukang Road, Pinghu Community, Pinghu Street, Longgang District, Shenzhen Guangdong, China, 518000
- Owner or operator
- Shenzhen Sany Pioneer Technology Co.,Ltd (10062741)
- Roles
- Manufacturer
- First device listed
- January 10, 2022
- Registered through
- 2027
- Brand names listed
- CPAP Mask Set, Connecting Hose for Wisp, Quick-Release Elbow Swivel Tube, Cushion, Elbow, Everness Anti Snoring Mouthpiece L07, Headbands, Headgear, Headgear Strap and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Device, Anti-Snoring | LRK | 2 | Manufacturer | accessdata.fda.gov |
| Device, Jaw Repositioning | LQZ | 2 | Manufacturer | accessdata.fda.gov |
| Dilator, Nasal | LWF | 1 | Manufacturer | accessdata.fda.gov |
| Mask, Oxygen | BYG | 1 | Manufacturer | accessdata.fda.gov |
| Set, Tubing And Support, Ventilator (W Harness) | BZO | 1 | Manufacturer | accessdata.fda.gov |
| Strap, Head, Gas Mask | BTK | 1 | Manufacturer | accessdata.fda.gov |
| Tubing, Pressure And Accessories | BYX | 1 | Manufacturer | accessdata.fda.gov |
| Ventilator, Non-Continuous (Respirator) | BZD | 2 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| August 27, 2026 | K262104 | Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT) | LRK | Substantially Equivalent | Ram.Shaw Pte., Ltd. | accessdata.fda.gov |
| May 21, 2026 | K251920 | Sleep Apnea Breathing Therapy Mask:JoyMask 20-B Full Face Mask, JoyMask 21-B Full Face Mask | BZD | Substantially Equivalent | Dcstar, Inc. | accessdata.fda.gov |
| March 3, 2026 | K253845 | Anti Snoring Mouthpiece (L08-BP, L08-PT, L08-BT, L08-TP, L08-TB, L08-PB) | LRK | Substantially Equivalent | Ram.Shaw Pte. , Ltd. | accessdata.fda.gov |
| October 22, 2025 | K251628 | Mandibular Advancement Device L07 | LRK | Substantially Equivalent | Dcstar, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Mask, Oxygen
- All makers of Set, Tubing And Support, Ventilator (W Harness)
- All makers of Ventilator, Non-Continuous (Respirator)
- All makers of Device, Anti-Snoring
- All makers of Device, Jaw Repositioning
- All makers of Tubing, Pressure And Accessories
Updated August 27, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.