Soring GmbH, Sonoca 300
FDA 510(k) K992026 · Soring GmbH Medizintechnik
510(k) numberK992026
Submission
- Device name
- Soring GmbH, Sonoca 300
- Applicant
- Soring GmbH Medizintechnik
Cincinnati, OH, US - Received
- June 16, 1999
- Decision date
- September 23, 1999
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BTA – Pump, Portable, Aspiration (Manual Or Powered)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
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| K260134 | Baby Nasal Aspirator (BN006, BN006-A, BN006-B, BN006-C, BN006-D, BN02; BN008, BN008-A…BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/15/2026SE |
| K260892 | Suction Pump (SU-90)BTA · Traditional | Shenzhen HugeMed Medical Technical Development… | 05/14/2026SE |
| K260473 | Electric nasal aspirator (BC027, BC030, BC033, BC035, BC035B)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 05/12/2026SE |
| K253107 | Electric Nasal Aspirator (DT10 and DT50, DX80, DX85, DX86 and DX90)BTA · Traditional | Shenzhen Dongjiang Technology Co., Ltd. | 04/14/2026SE |
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| K251450 | Baby Nasal Aspirator (BN002); Baby Nasal Aspirator (BN006); Baby Nasal Aspirator…BTA · Special | Shenzhen Desida Technology Co., Ltd. | 06/06/2025SE |
| K244033 | Electric Nasal Aspirator (NASA601,NASA602,NASA603,NASA605,NASA606,NASA608,NASA610)BTA · Traditional | Shenzhen Desida Technology Co., Ltd. | 05/16/2025SE |
| K251101 | AIRO Suction Unit (AIRO-01)BTA · Traditional | Cro, LLC | 04/26/2025SE |
| K250697 | Electric Nasal Aspirator (BC026, BC025, BC023)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 04/23/2025SE |
More from Shenzhen Kingboom Technology Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K093511 | Soring MBC200/BCC140GEI · Traditional | 04/16/2010SE |
| K052183 | Soring GmbH Sonoca LipoQPB · Traditional | 10/07/2005SE |
| K030028 | CPC by Soring GmbHGEI · Special | 01/17/2003SE |
| K024059 | MBC SeriesGEI · Special | 01/08/2003SE |
| K012753 | Soring GmbH Sonoca 180/190LFL · Traditional | 11/13/2001SE |
| K993265 | Soring GmbH, Arco 3000, Arco 2000, Arco 1000, MBC 601, MBC 600GEI · Special | 10/22/1999SE |
Questions and answers
When was Soring GmbH, Sonoca 300 cleared by the FDA?
Soring GmbH, Sonoca 300 (K992026) received a 510(k) decision of Substantially Equivalent on September 23, 1999, 99 days after the submission was received.
What is the product code of K992026?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.