Hangzhou Hua'An Medical & Health Instruments Co.,: FDA filings under this applicant name

FDA lists 10 510(k) clearances under the applicant name “Hangzhou Hua'An Medical & Health Instruments Co.,” (first 2003, latest 2018), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 100 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.

510(k) clearances per year

Review time against the same product codes

Since 2017, 510(k)s cleared under the name Hangzhou Hua'An Medical & Health Instruments Co., took a median 118 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 182 days.

Top product codes

Review panels

• General Hospital (8)
• Cardiovascular (2)

Most recent Hangzhou Hua'An Medical & Health Instruments Co., 510(k) clearances

Recalls

openFDA lists no recalls under a recalling firm named Hangzhou Hua'An Medical & Health Instruments Co.,.

Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.

Other FDA applicant names starting with the same word

FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.

• Hangzhou AGS MedTech Co., Ltd. (19 510(k)s)
• Hangzhou AllTest Biotech Co., Ltd. (14 510(k)s)
• Hangzhou Clongene Biotech Co., Ltd. (9 510(k)s)
• Hangzhou Qiantang Longyue Biotechnology Co., Ltd. (6 510(k)s)
• Hangzhou SHINING3D Dental Technology Co., Ltd. (5 510(k)s)
• Hangzhou Bever Medical Devices Co., Ltd. (4 510(k)s)
• Hangzhou Jimushi Meditech Co., Ltd. (3 510(k)s)
• Hangzhou Kangji Medical Instrument Co., Ltd. (3 510(k)s)
• Hangzhou Laihe Biotech Co., Ltd. (3 510(k)s)
• Hangzhou Tappa Medical Technology Co., Ltd. (3 510(k)s)
• Hangzhou Primecare Medical Co., Ltd. (2 510(k)s)
• Hangzhou Runheng Medical Co., Ltd. (2 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Hangzhou Hua'An Medical & Health Instruments Co.,?

FDA lists 10 510(k) clearances under the applicant name “Hangzhou Hua'An Medical & Health Instruments Co.,” (first 2003, latest 2018), across 2 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Hangzhou Hua'An Medical & Health Instruments Co.,?

The median time from FDA receipt to decision across 510(k)s cleared under the name Hangzhou Hua'An Medical & Health Instruments Co., is 100 days.

Which FDA product codes appear under Hangzhou Hua'An Medical & Health Instruments Co.,?

The most frequent FDA product codes under this applicant name are FLL (Continuous Measurement Thermometer, 8); DXN (System, Measurement, Blood-Pressure, Non-Invasive, 2).

Next steps

• See all 10 Hangzhou Hua'An Medical & Health Instruments Co., clearances with predicates and recalls
• Run predicate analysis for product code FLL, Hangzhou Hua'An Medical & Health Instruments Co.,'s most frequent

Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.

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