Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui): FDA filings under this applicant name

FDA lists 8 510(k) clearances under the applicant name “Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)” (first 2016, latest 2021), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 124 days. Since 2017 the median was 127 days, against 99 days for all cleared 510(k)s in the same product codes. 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 Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) took a median 127 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 99 days.

Top product codes

Review panels

• Radiology (8)

Most recent Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) 510(k) clearances

Recalls

openFDA lists no recalls under a recalling firm named Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui).

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.

• Shantou Institute of Ultrasonic Instuments (11 510(k)s)
• Shantou Wealy Medical Instrument Co.,Ltd (6 510(k)s)
• Shantou Institute of Ultrasonic Instruments (Siui (5 510(k)s)
• Shantou Institute of Ultrasonic Instruments Co., Ltd. (3 510(k)s)
• Shantou Xinghe Electrical Apparatuses Co., Ltd. (2 510(k)s)
• Shantou Huihengqi Electronic Technology Co., Ltd. (1 510(k)s)
• Shantou T&K Medical Equipment Factory Co.,Ltd (1 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)?

FDA lists 8 510(k) clearances under the applicant name “Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)” (first 2016, latest 2021), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.

How long has FDA taken to clear 510(k)s filed by Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)?

The median time from FDA receipt to decision across 510(k)s cleared under the name Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) is 124 days. Since 2017: 127 days, versus 99 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)?

The most frequent FDA product codes under this applicant name are IYN (System, Imaging, Pulsed Doppler, Ultrasonic, 4); IZL (System, X-Ray, Mobile, 4).

Next steps

• See all 8 Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui) clearances with predicates and recalls
• Run predicate analysis for product code IYN, Shantou Institute of Ultrasonic Instruments Co., Ltd. (Siui)'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.

All FDA device companies · FDA product code lookup