Shanghai Apolo Medical Technology Co., Ltd.: FDA filings under this applicant name

FDA lists 14 510(k) clearances under the applicant name “Shanghai Apolo Medical Technology Co., Ltd.” (first 2019, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 89 days. Since 2017 the median was 89 days, against 94 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 Shanghai Apolo Medical Technology Co., Ltd. took a median 89 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 94 days.

Top product codes

Review panels

• General and Plastic Surgery (13)
• Physical Medicine (1)

Most recent Shanghai Apolo Medical Technology Co., Ltd. 510(k) clearances

4 earlier clearances. See the full list in Caduvo.

Recalls

openFDA lists no recalls under a recalling firm named Shanghai Apolo Medical Technology Co., Ltd..

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.

• Shanghai United Imaging Healthcare Co., Ltd. (85 510(k)s)
• Shanghai AnQing Medical Instrument Co., Ltd. (14 510(k)s)
• Shanghai Antares Industries, Inc. (14 510(k)s)
• Shanghai Palomar Mountain Industries, Inc. (12 510(k)s)
• Shanghai Sanyou Medical Co, Ltd. (9 510(k)s)
• Shanghai Chenguang Medical Technologies Co, Ltd. (8 510(k)s)
• Shanghai Motex Healthcare Co., Ltd. (8 510(k)s)
• Shanghai Poseidon Plastic Products Co., Ltd. (8 510(k)s)
• Shanghai Champion Plastic Products Co., Ltd. (6 510(k)s)
• Shanghai PT Plastics Enterprise Company, Ltd. (6 510(k)s)
• Shanghai SeeGen Photoelectric Technology Co., Ltd. (6 510(k)s)
• Shanghai Wonderful Opto-Electrics Tech.Co.,Ltd (6 510(k)s)

Frequently asked questions

How many FDA 510(k) clearances are listed under Shanghai Apolo Medical Technology Co., Ltd.?

FDA lists 14 510(k) clearances under the applicant name “Shanghai Apolo Medical Technology Co., Ltd.” (first 2019, latest 2026), across 5 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 Shanghai Apolo Medical Technology Co., Ltd.?

The median time from FDA receipt to decision across 510(k)s cleared under the name Shanghai Apolo Medical Technology Co., Ltd. is 89 days. Since 2017: 89 days, versus 94 days for all cleared 510(k)s in the same product codes.

Which FDA product codes appear under Shanghai Apolo Medical Technology Co., Ltd.?

The most frequent FDA product codes under this applicant name are GEX (Powered Laser Surgical Instrument, 9); ONG (Powered Laser Surgical Instrument With MicrobeamFractional Output, 2); NGX (Stimulator, Muscle, Powered, For Muscle Conditioning, 1).

Next steps

• See all 14 Shanghai Apolo Medical Technology Co., Ltd. clearances with predicates and recalls
• Run predicate analysis for product code GEX, Shanghai Apolo Medical Technology Co., Ltd.'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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