Autovac
FDA 510(k) K921107 · Life Support Products, Inc.
510(k) numberK921107
Submission
- Device name
- Autovac
- Applicant
- Life Support Products, Inc.
Irvine, CA, US - Received
- March 9, 1992
- Decision date
- September 17, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement 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
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 |
|---|---|---|
| K941871 | Lspi Automatic Ventilator, Model AV3000-100BTL · Traditional | 01/09/1995SE |
| K941870 | Lspi Automatic Ventilator, Model AV2000-100BTL · Traditional | 01/09/1995SE |
| K940934 | Life VacBTA · Traditional | 05/03/1994SE |
| K936187 | Lspi Pressure RegulatorCAN · Traditional | 01/27/1994SE |
| K932200 | Lspi Automatic VentilatorBTL · Traditional | 11/24/1993SE |
| K932199 | Lspi Automatic Ventilator, Model AV3000BTL · Traditional | 11/24/1993SE |
| K922819 | Infant Disposable Bag Mask ResuscitatorBTM · Traditional | 11/24/1993SE |
| K922691 | LSP (Model 554) Bag Mask ResuscitatorBTM · Traditional | 11/24/1993SE |
| K921553 | Lspi Infant Bag MaskBTM · Traditional | 10/19/1992SE |
| K924217 | Lspi Disposable Bag Mask Resuscitator/ModifiedBTM · Traditional | 09/17/1992SE |
Questions and answers
When was Autovac cleared by the FDA?
Autovac (K921107) received a 510(k) decision of Substantially Equivalent on September 17, 1992, 192 days after the submission was received.
What is the product code of K921107?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.