Vision Rt, Ltd.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Vision Rt, Ltd.” (first 2018, latest 2026), across 1 product code in 1 review panel. Median 510(k) review time under this name: 99 days. Since 2017 the median was 99 days, against 106 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 |
|---|---|---|
| 2018 | 1 | 92 |
| 2019 | 0 | — |
| 2020 | 1 | 24 |
| 2021 | 2 | 96 |
| 2022 | 0 | — |
| 2023 | 1 | 58 |
| 2024 | 1 | 137 |
| 2025 | 1 | 213 |
| 2026 | 1 | 180 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Vision Rt, Ltd. took a median 99 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 106 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 8 | 8 |
Review panels
- Radiology (8)
Most recent Vision Rt, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K253012 | AlignRT Plus (8.0) | IYE | 2026-03-18 | 180 |
| K243301 | MapRT | IYE | 2025-05-19 | 213 |
| K233622 | AlignRT Plus | IYE | 2024-03-29 | 137 |
| K231185 | MapRT | IYE | 2023-06-23 | 58 |
| K212583 | AlignRT Plus | IYE | 2021-11-10 | 86 |
| K203387 | AlignRT Plus | IYE | 2021-03-04 | 106 |
| K193431 | AlignRT Plus | IYE | 2020-01-03 | 24 |
| K181218 | AlignRT Plus | IYE | 2018-08-07 | 92 |
Recalls
6 product recalls in 5 recall events; 1 initiated in the last five years. Most recent: 2025-08-27.
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.
- Vision Quest Industries, Inc. (6 510(k)s)
- Vision Health Technology (3 510(k)s)
- Vision Medical, Inc. (3 510(k)s)
- Vision RT Limited (3 510(k)s)
- Vision Biosystems, Inc. (2 510(k)s)
- Vision Electronics (2 510(k)s)
- Vision Quest Industries Inc./Dba VQ Orthocare (2 510(k)s)
- Vision Science Co., Ltd. (2 510(k)s)
- Vision Systems Group, A Division of Viking Systems (2 510(k)s)
- Vision Ten, Inc. (2 510(k)s)
- Vision Chips, Inc. (1 510(k)s)
- Vision Design Eyewear, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Vision Rt, Ltd.?
FDA lists 8 510(k) clearances under the applicant name “Vision Rt, Ltd.” (first 2018, latest 2026), across 1 product code 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 Vision Rt, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Vision Rt, Ltd. is 99 days. Since 2017: 99 days, versus 106 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Vision Rt, Ltd.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 8).
Next steps
- See all 8 Vision Rt, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Vision Rt, 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.