605 Vacu-Max
FDA 510(k) K941961 · Medical Industries America, Inc.
510(k) numberK941961
Submission
- Device name
- 605 Vacu-Max
- Applicant
- Medical Industries America, Inc.
Adel, IA, US - Received
- April 22, 1994
- Decision date
- March 2, 1995
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary 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
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| K251101 | AIRO Suction Unit (AIRO-01)BTA · Traditional | Cro, LLC | 04/26/2025SE |
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| K942208 | 4003 AeroliteCAF · Traditional | 02/24/1995SE |
| K940630 | 503 Maxi CompressorBTI · Traditional | 02/21/1995SE |
| K905593 | SleepapBZD · Traditional | 04/23/1991SE |
Questions and answers
When was 605 Vacu-Max cleared by the FDA?
605 Vacu-Max (K941961) received a 510(k) decision of Substantially Equivalent on March 2, 1995, 314 days after the submission was received.
What is the product code of K941961?
The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.