Gomco Suction Pump Cabinet Change
FDA 510(k) K810490 · Allied Healthcare Products, Inc.
510(k) numberK810490
Submission
- Device name
- Gomco Suction Pump Cabinet Change
- Applicant
- Allied Healthcare Products, Inc.
Mchenry, IL, US - Received
- February 24, 1981
- Decision date
- March 13, 1981
- 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
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| K260892 | Suction Pump (SU-90)BTA · Traditional | Shenzhen HugeMed Medical Technical Development… | 05/14/2026SE |
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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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| K072214 | Portable Ventilator, Model EPV-100BTL · Traditional | 03/06/2008SE |
| K073171 | Resuscitation Timer, Model L770-CPRBTM · Traditional | 01/31/2008SE |
| K070636 | Autovent 4000 with CPAPBTL · Traditional | 07/13/2007SE |
| K070120 | Autovent Model 4000BTL · Traditional | 05/03/2007SE |
Questions and answers
When was Gomco Suction Pump Cabinet Change cleared by the FDA?
Gomco Suction Pump Cabinet Change (K810490) received a 510(k) decision of Substantially Equivalent on March 13, 1981, 17 days after the submission was received.
What is the product code of K810490?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.