Oriental Inspiration Limited: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Oriental Inspiration Limited” (first 2017, latest 2024), across 5 product codes in 3 review panels. Median 510(k) review time under this name: 154 days. Since 2017 the median was 154 days, against 98 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 |
|---|---|---|
| 2017 | 2 | 92 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 1 | 154 |
| 2022 | 1 | 198 |
| 2023 | 0 | — |
| 2024 | 1 | 207 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Oriental Inspiration Limited took a median 154 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 98 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 1 | 1 |
| KPI | Stimulator, Electrical, Non-Implantable, For Incontinence | 1 | 1 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 1 | 1 |
| OHT | Light Based Over-The-Counter Hair Removal | 1 | 1 |
| OLP | Over-The-Counter Powered Light Based Laser For Acne | 1 | 1 |
Review panels
Most recent Oriental Inspiration Limited 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K233046 | Electrical Neuromuscular Stimulator, Cure Trio | GZJ | 2024-04-19 | 207 |
| K213133 | Keffort (MC-100, MC-100A) | KPI | 2022-04-13 | 198 |
| K212285 | Electrical Neuromuscular Stimulator (Cure Trio MC-310 iOS, Cure Trio MC-310 Android) | NUH | 2021-12-22 | 154 |
| K170269 | Hee HR Mini | OHT | 2017-05-03 | 96 |
| K170260 | BC-001+ Acne Purifier | OLP | 2017-04-25 | 88 |
Recalls
openFDA lists no recalls under a recalling firm named Oriental Inspiration Limited.
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 Oriental Inspiration Limited (a text match, not an official crosswalk):
- L8678 — Electrical stimulator supplies (external) for use with implantable neurostimulator, per month (via KPI)
- C1767 — Generator, neurostimulator (implantable), non-rechargeable (via KPI)
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.
- Oriental Medical Supplies, Inc. (6 510(k)s)
- Oriental System Technology, Inc. (6 510(k)s)
- Oriental Inspiration, Ltd. (1 510(k)s)
- Oriental Resources Development Limited (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Oriental Inspiration Limited?
FDA lists 5 510(k) clearances under the applicant name “Oriental Inspiration Limited” (first 2017, latest 2024), across 5 product codes in 3 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 Oriental Inspiration Limited?
The median time from FDA receipt to decision across 510(k)s cleared under the name Oriental Inspiration Limited is 154 days. Since 2017: 154 days, versus 98 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Oriental Inspiration Limited?
The most frequent FDA product codes under this applicant name are GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 1); KPI (Stimulator, Electrical, Non-Implantable, For Incontinence, 1); NUH (Stimulator, Nerve, Transcutaneous, Over-The-Counter, 1).
Next steps
- See all 5 Oriental Inspiration Limited clearances with predicates and recalls
- Run predicate analysis for product code GZJ, Oriental Inspiration 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.