Tracheostomy and Nasal Suctioning Kit
Which Manufacturers in China Make This?
6 manufacturers in China hold an FDA registration for this device type, concentrated in Jiangsu, Guangdong and Henan, and 2 other provinces. 2 of them are contract manufacturers, able to build to a buyer’s own specification.
- Allmed Medical Products Co., Ltd. Hubei, contract manufacturer
- Allmed Industrial Limited Guangdong
- Henan Yadu Industrial Co., Ltd. Henan, contract manufacturer
- Hangzhou Primecare Medical Co., Ltd. Zhejiang, contract manufacturer
- Jiangsu NEW Pentastar Medical Products Co., Ltd. Jiangsu
- Primecare Medical (Suzhou) Co., Ltd. Jiangsu, contract manufacturer
What Is It?
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 type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.
What Is FDA Product Code LRQ?
Tracheostomy And Nasal Suctioning Kit is FDA product code LRQ, Class 1.
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 4 recalls under this product code since 2019. None was by a company in China. 2 are Class I, the most serious grade.
The root causes the FDA records most often are Nonconforming Material/Component (2) and Packaging process control (2). A recall is a fact about one product and its maker, not a grade for every manufacturer of the type.