AG Mass
FDA 510(k) K131099 · Hospitech Respiration , Ltd.
510(k) numberK131099
Submission
- Device name
- AG Mass
- Applicant
- Hospitech Respiration , Ltd.
Binyamina, IL - Received
- April 19, 2013
- Decision date
- May 13, 2013
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 878.4780
- Specialty
- General, Plastic Surgery
Other 510(k)s with product code JCX
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K250964 | Protable Phlegm Suction Unit (JMA D01)JCX · Traditional | Jiangsu Jumao X-Care Medical Equipment Co., Ltd. | 05/11/2026SE |
| K243638 | MV Flow Aspiration Pump (MVFLOWPMP01)JCX · Traditional | Microvention | 06/13/2025SE |
| K251111 | CaryJCX · Traditional | Excitus AS | 05/07/2025SE |
| K243418 | Riptide Aspiration Pump; Riptide Collection Canister with Intermediate TubingJCX · Special | Micro Therapeutics, Inc. d/b/a ev3 Neurovascular | 12/02/2024SE |
| K233428 | Easycess Aspiration PumpJCX · Traditional | Guangzhou Easycess Medical Co.,Ltd | 11/03/2023SE |
| K222552 | 120V Neptune S Rover (0711-001-000);V2 4-Port Manifold (0750-400-000);V2 Specimen…JCX · Traditional | Stryker Instruments | 12/09/2022SE |
| K182950 | Acare Suction UnitJCX · Traditional | Acare Technology Co., Ltd. | 08/23/2019SE |
| K190789 | IntelliCartTM SystemJCX · Special | Dornoch Medical Systems | 04/24/2019SE |
| K190105 | ZOOM Aspiration PumpJCX · Special | Taiwan Biomaterial Co., Ltd. | 02/21/2019SE |
| K180115 | TWBM PumpJCX · Traditional | Taiwan Biomaterial Co., Ltd. | 07/24/2018SE |
More from Taiwan Biomaterial Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K221477 | AG100sBSK · Traditional | 12/29/2022SE |
| K180991 | AG 100sBSK · Traditional | 10/12/2018SE |
| K150157 | AnapnoGuard 100 Respiratory Guard SystemBSK · Traditional | 02/16/2016SE |
| K122721 | AG GuffillBSK · Traditional | 05/03/2013SE |
| K093126 | Anapnoguard Endotracheal TubeBTP · Traditional | 03/02/2010SE |
Questions and answers
When was AG Mass cleared by the FDA?
AG Mass (K131099) received a 510(k) decision of Substantially Equivalent on May 13, 2013, 24 days after the submission was received.
What is the product code of K131099?
The FDA product code is JCX – Apparatus, Suction, Ward Use, Portable, Ac-Powered, a Class II (moderate risk) device regulated under 21 CFR 878.4780.