Hsiner Co., Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Hsiner Co., Ltd.” (first 2005, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 96 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
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 1 | 265 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Hsiner Co., Ltd. took a median 265 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 236 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| CAF | Nebulizer (Direct Patient Interface) | 3 | 3 |
| CBK | Ventilator, Continuous, Facility Use | 2 | 2 |
| BTM | Ventilator, Emergency, Manual (Resuscitator) | 1 | 1 |
| BZD | Ventilator, Non-Continuous (Respirator) | 1 | 1 |
| CAH | Filter, Bacterial, Breathing-Circuit | 1 | 1 |
Review panels
- Anesthesiology (7)
- General Hospital (1)
Most recent Hsiner Co., Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251888 | VPAP Pediatric Face Mask | CBK | 2026-03-12 | 265 |
| K102120 | NIPPV SILICONE FACE MASK, NIPPV ECONOMY FACE MASK, NIPPV SILICONE NASAL MASK MODEL 10212, 10222, 10202 | CBK | 2011-08-12 | 379 |
| K091185 | 70530-BACTIAL/VIRAL FILTER, 70531-HMEF, 70536-BACTERIAL/VIRAL FILTER | CAH | 2009-07-24 | 92 |
| K082009 | HSINER NEBULIZER BOTTLE, CPR MASKS AND FACE SHIELDS | CAF | 2008-08-22 | 30 |
| K070948 | HSINER NEBULIZER BOTTLE | CAF | 2007-04-25 | 21 |
| K063268 | CPAP/VPAP MASKS, MODELS 1225, 1205 AND 1235 | BZD | 2007-02-23 | 116 |
| K053466 | HSINER RESUSCITATOR | BTM | 2006-03-22 | 99 |
| K052811 | HSINER JET NEBULIZER, MODEL HS-31100 | CAF | 2005-12-21 | 78 |
Recalls
openFDA lists no recalls under a recalling firm named Hsiner 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.
Related HCPCS codes
HCPCS Level II codes whose descriptors match the device names of the product codes filed under Hsiner Co., Ltd. (a text match, not an official crosswalk):
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.
- Hsiner Company (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Hsiner Co., Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Hsiner Co., Ltd.” (first 2005, 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 Hsiner Co., Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Hsiner Co., Ltd. is 96 days.
Which FDA product codes appear under Hsiner Co., Ltd.?
The most frequent FDA product codes under this applicant name are CAF (Nebulizer (Direct Patient Interface), 3); CBK (Ventilator, Continuous, Facility Use, 2); BTM (Ventilator, Emergency, Manual (Resuscitator), 1).
Next steps
- See all 8 Hsiner Co., Ltd. clearances with predicates and recalls
- Run predicate analysis for product code CAF, Hsiner 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.