Egnell Universal Suction Pump
FDA 510(k) K853909 · Egnell, Inc.
510(k) numberK853909
Submission
- Device name
- Egnell Universal Suction Pump
- Applicant
- Egnell, Inc.
Chicago, IL, US - Received
- September 20, 1985
- Decision date
- November 25, 1985
- Decision
- Substantially Equivalent for Some Indications (SN)
- 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 |
|---|---|---|
| K853917 | Egnell Compact Suction PumpBTA · Traditional | 11/25/1985SN |
| K844307 | Egnell-Lact B Battery-Operated Breast PumpHGX · Traditional | 02/04/1985SE |
| K840526 | AmethermFMZ · Traditional | 04/30/1984SE |
| K834335 | Ameda Phototherapy Lamp for NewbornLBI · Traditional | 04/20/1984SE |
| K832637 | Ameda Neonatal Resuscitation Unit-FMT · Traditional | 12/22/1983SE |
| K813312 | Universal Suction Pump Type EusBTA · Traditional | 12/31/1981SE |
| K813095 | Gastric Juices Suction PumpBTA · Traditional | 12/09/1981SE |
| K812898 | PE-01 Electronic Infusion PumpFRN · Traditional | 12/02/1981SE |
| K812020 | Egnell Compact, Type EhvBTA · Traditional | 10/20/1981SE |
Questions and answers
When was Egnell Universal Suction Pump cleared by the FDA?
Egnell Universal Suction Pump (K853909) received a 510(k) decision of Substantially Equivalent for Some Indications on November 25, 1985, 66 days after the submission was received.
What is the product code of K853909?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.