Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model 31.00.XX
FDA 510(k) K011601 · Ardo Medical AG
510(k) numberK011601
Submission
- Device name
- Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model 31.00.XX
- Applicant
- Ardo Medical AG
Unterageri, CH - Received
- May 24, 2001
- Decision date
- June 8, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
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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| K253629 | Momcozy Nasal Aspirator (BN007)BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/26/2026SE |
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| 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 |
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| K172067 | One Mum PumpsetHGX · Special | 11/29/2017SE |
| K150721 | ARDO Calypso Pro Powered Breast PumpHGX · Traditional | 06/17/2015SE |
| K141742 | Ardo Carum and Calypso Powered Breast PumpsHGX · Traditional | 10/17/2014SE |
Questions and answers
When was Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model 31.00.XX cleared by the FDA?
Ardo Suction Pump Master, Model 30.00.XX; Ardo Suction Pump Senator, Model 31.00.XX (K011601) received a 510(k) decision of Substantially Equivalent on June 8, 2001, 15 days after the submission was received.
What is the product code of K011601?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.