Van Dellen Aspirator
FDA 510(k) K873462 · Van Dellen, Ltd.
510(k) numberK873462
Submission
- Device name
- Van Dellen Aspirator
- Applicant
- Van Dellen, Ltd.
Tucson, AZ, US - Received
- August 28, 1987
- Decision date
- September 25, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
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
Other 510(k)s with product code BTA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K253629 | Momcozy Nasal Aspirator (BN007)BTA · Traditional | Shenzhen Root Innovation Technology Co., Ltd. | 05/26/2026SE |
| 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 |
| K260147 | Electric nasal aspirator (BC026, BC025, BC023, BC028, BC029, BC036)BTA · Traditional | Shenzhen Kingboom Technology Co., Ltd. | 03/13/2026SE |
| 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 |
|---|---|---|
| K873465 | Van Dellen Bacteria FilterFPK · Traditional | 01/20/1988SE |
| K873464 | Van Dellen CannulaJOL · Traditional | 11/23/1987SE |
| K873463 | Van Dellen Aspirating TubingBYY · Traditional | 11/23/1987SE |
| K873164 | Van Dellen Healon CannulaHMX · Traditional | 09/04/1987SE |
| K873163 | Van Dellen Irrigating CystotomeHNY · Traditional | 09/04/1987SE |
| K873162 | Van Dellen Retrobulbar NeedleHMX · Traditional | 09/04/1987SE |
Questions and answers
When was Van Dellen Aspirator cleared by the FDA?
Van Dellen Aspirator (K873462) received a 510(k) decision of Substantially Equivalent on September 25, 1987, 28 days after the submission was received.
What is the product code of K873462?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.