Chest Drainage Kit
Who Makes This Device Type in China?
2 manufacturers in China hold an FDA registration for this device type, based in Zhejiang.
- GRI Medical & Electronic Technology Co., Ltd. Zhejiang, contract manufacturer
- Ningbo HLS Medical Products Co., Ltd. Zhejiang
What Is This Device?
This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov/cdrh/ode/convkit.html. This kit, as described in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market.
How Is PAD Classified?
Chest Drainage Kit is FDA product code PAD, Class 2, 21 CFR 880.6740.
What Does It Take to Sell It in the United States?
The FDA exercises enforcement discretion for this code and does not currently require a premarket submission for devices that meet the conditions it has set for it.
What Has Gone Wrong With It?
The FDA has recorded 20 recalls under this product code since 2015. None was by a company in China. 1 is Class I, the most serious grade.
The root causes the FDA records most often are Package design/selection (10), Process control (6) and Nonconforming Material/Component (1). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.