Ga Health Company Limited: FDA filings under this applicant name
FDA lists 12 510(k) clearances under the applicant name “Ga Health Company Limited” (first 2020, latest 2023), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 96 days. Since 2017 the median was 96 days, against 121 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
| Year | Clearances | Median review days |
|---|---|---|
| 2020 | 5 | 97 |
| 2021 | 1 | 161 |
| 2022 | 2 | 70 |
| 2023 | 4 | 93 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Ga Health Company Limited took a median 96 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 121 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OCX | Endoscopic Irrigation/Suction System | 6 | 6 |
| ODC | Endoscope Channel Accessory | 4 | 4 |
| KTI | Bronchoscope Accessory | 1 | 1 |
| OCU | Endoscopic Storage Cover | 1 | 1 |
Review panels
Most recent Ga Health Company Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K232118 | ANDORATE® Valve Kit | ODC | 2023-10-16 | 91 |
| K231602 | Protego Air Water Connector; Protego Air Water Bottle Tubing; Protego Hybrid Tubing | OCX | 2023-08-01 | 61 |
| K230932 | ANDORATE® Valve Kit | OCX | 2023-07-07 | 95 |
| K230280 | ANDORATE® Suction Valve and ANDORATE® Biopsy Valve | KTI | 2023-05-11 | 99 |
| K223171 | AquaPulse® Irrigation Tubing | OCX | 2022-11-10 | 30 |
| K213095 | andorate Suction Valve, andorate Air/Water Valve | ODC | 2022-01-12 | 110 |
| K202838 | Andorate Universal Endoscope Tip Guard | OCU | 2021-03-05 | 161 |
| K202560 | AquaPulse Irrigation Tubing | OCX | 2020-12-10 | 97 |
| K200495 | Andorate Disposable Air/Water Valve, Andorate Disposable Suction Valve | ODC | 2020-06-24 | 117 |
| K200481 | Andorate Biopsy Valve, Andorate Biopsy Irrigator | ODC | 2020-06-18 | 112 |
2 earlier clearances. See the full list in Caduvo.
Recalls
11 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2020-11-03.
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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Ga Health Company Limited?
FDA lists 12 510(k) clearances under the applicant name “Ga Health Company Limited” (first 2020, latest 2023), across 4 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 Ga Health Company Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Ga Health Company Limited is 96 days. Since 2017: 96 days, versus 121 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Ga Health Company Limited?
The most frequent FDA product codes under this applicant name are OCX (Endoscopic Irrigation/Suction System, 6); ODC (Endoscope Channel Accessory, 4); KTI (Bronchoscope Accessory, 1).
Next steps
- See all 12 Ga Health Company Limited clearances with predicates and recalls
- Run predicate analysis for product code OCX, Ga Health Company Limited'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.