Pneumostat
Pneumostat Chest Drain Valve
88manufacturers in China registered for this device type
1catalogue number
8510(k) clearances naming this product code
11recalls on this code
Who Else Makes It
Concentrated in Guangdong (26), Jiangsu (25), Zhejiang (17). 15 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Amsino Medical (Kunshan) Co., Ltd. | Kunshan | Jiangsu | Contract manufacturer | 53 |
| Jiangsu JianYu Health Medical Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 35 |
| Zhejiang Chuangxiang Medical Technology Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 27 |
| Suzhou Jinsheng Plastic Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 23 |
| Ningbo Great Mountain Medical Instruments Co., Ltd. | Ningbo | Zhejiang | Contract manufacturer | 12 |
| Hangzhou Jinlin Medical Appliances Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 11 |
| JIE GAO Plastic Products Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 11 |
| Medwell Technology Limited | Dongguan | Guangdong | Contract manufacturer | 10 |
| Changzhou Health Microport Medical Device Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 10 |
| Rongxing Plastic Jurong Co., Ltd. | Zhenjiang | Jiangsu | Contract manufacturer | 8 |
| Zhejiang Aicor Medical Technology Co., Ltd. | Linhai | Zhejiang | Contract manufacturer | 4 |
Showing 12 of 88. All 88 manufacturers in China registered for Bottle, Collection, Vacuum
Record
| Listed by | Atrium Medical Corporation, United States |
|---|---|
| FDA product code | KDQ |
| Device type | Bottle, Collection, Vacuum |
| Device class | Class 2 |
| Regulation | 21 CFR 880.6740 |
| Establishment | Specification developer, Manufacturer, Exporter |
| 510(k) | K984496 |
| Record published | 2015-09-24 |
| Record revised | 2024-01-09 (version 6) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Packaging | Pack of 10 |
| Distribution end date | 2023-05-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 16100 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DeRoyal | Deroyal Industries, Inc. | 191 |
| Pleur-Evac | Teleflex Medical LLC | 58 |
| Bemis | Bemis Manufacturing Co. | 41 |
| Suction Liner | Shijiazhuang Yuanding Medical Device Co., Ltd. | 40 |
| Medline | Medline Industries, Inc. | 26 |
| Allied Medical LLC | Allied Medical LLC | 25 |
| Suction Liner System | Shijiazhuang Yuanding Medical Device Co., Ltd. | 20 |
| Thora-Vent Thoracic Vent | Uresil, LLC | 16 |
| Medline Industries, Inc. | Medline Industries, Inc. | 15 |
| Bottle, Collection, Vacuum | Carilex Medical, Inc. | 13 |
| Ocean | Atrium Medical Corporation | 13 |
| McKesson | Mckesson Medical-Surgical Inc. | 13 |
Showing 12 of 216. All products under Bottle, Collection, Vacuum
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K081718 | 2008-07-25 |
| K043582 | 2005-01-21 |
| K984496 | 1999-05-05 |
| K950677 | 1995-04-13 |
| K912704 | 1991-08-26 |
| K897125 | 1990-03-30 |
| K860023 | 1986-01-10 |
| K851892 | 1985-06-14 |
Recalls Naming This Product
2 recalls name this product by its own identifiers, the UDI on its label or the 510(k) it is cleared under.
| Recalled by | Identified by | Initiated | FDA class | Root cause | Reason | Quantity |
|---|---|---|---|---|---|---|
| Atrium Medical Corporation | UDI-DI | 2023-03-01 | Class II | Under Investigation by firm | The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide suf | 3554 cases of 10 |
| Atrium Medical Corporation | 510(k) number | 2021-08-26 | Class II | Under Investigation by firm | The firm is revising the Indication for Use, Contraindications, Warnings, and Precautions, after the device was involved in the treatment of a preterm infant who later died. | 92,430 units |
Recalls
9 of these are Class II. Class II means a temporary or reversible health consequence. Volume alone is not a quality signal: a manufacturer that ships more recalls more.
| Initiated | FDA class | Root cause | Reason | Quantity | Closed |
|---|---|---|---|---|---|
| 2023-09-05 | Class II | Labeling mix-ups | Product was re-processed and re-sterilized by a third party using packaging configurations and a sterilization process which are not approved by the manufacture and lack validation. | ||
| 2023-03-01 | Class II | Under Investigation by firm | The Instructions for Use (IFU) for the Pneumostat Chest Drain Valve and the Express Mini 500 Dry Seal Chest Drains do not provide sufficient precaution against draining the device for continued use. Additionally, the IFUs do not provide suf | 8184 cases of 6 | |
| 2022-10-18 | Class II | Storage | Warehouse experienced temperature excursions in July and August 2021. It was determined that there were no associated harms to patients. | 24 units (4cases/6) | |
| 2021-10-22 | Class II | Labeling design | Inadequate/inappropriate Set-Up Instructions, which may result in delay in treatment and an unreasonable risk of harm to the patient | 87,972 drains (14,662 cases; 6 units/case) | |
| 2016-12-23 | Class II | Process control | Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. | 1 case (6 units) | 2020-11-03 |
| 2016-12-23 | Class II | Process control | Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. | 245 cases (1470 units) | 2020-11-03 |
| 2016-12-23 | Class II | Process control | Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. | 27 cases (162 units) | 2020-11-03 |
| 2016-12-23 | Class II | Process control | Chest drains manual vent valve located at the top of affected chest drains could potentially not re-seal after being depressed. | 1 case (6 units) | 2020-11-03 |
| 2013-07-16 | Class II | Labeling Change Control | Individual component’s IFUs are not included with the kit. | 6,516 units | 2014-07-15 |
Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.