Sra Developments, Ltd.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Sra Developments, Ltd.” (first 2003, latest 2022), across 2 product codes in 2 review panels. Median 510(k) review time under this name: 92 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 | 1 | 84 |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 1 | 245 |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sra Developments, Ltd. took a median 245 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 120 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| LFL | Instrument, Ultrasonic Surgical | 4 | 4 |
| JDX | Instrument, Surgical, Sonic And Accessory/Attachment | 1 | 1 |
Review panels
Most recent Sra Developments, Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K221102 | LOTUS Series 4 Enhanced Shears, LOTUS Series 5 | LFL | 2022-12-15 | 245 |
| K151101 | Lotus Series 4 Ultrasonic Surgical System & Accessories | LFL | 2015-07-17 | 84 |
| K072961 | LOTUS ULTRASONIC SYSTEM FOR CEMENTED IMPLANT EXTRACTION (USCIX) | JDX | 2007-12-19 | 61 |
| K063531 | SERIES 3 LOTUS LAPAROSCOPIC ULTRASOUND SURGERY SYSTEM | LFL | 2007-02-22 | 92 |
| K032424 | LOTUS | LFL | 2003-12-16 | 133 |
Recalls
openFDA lists no recalls under a recalling firm named Sra Developments, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Sra Developments, Ltd.?
FDA lists 5 510(k) clearances under the applicant name “Sra Developments, Ltd.” (first 2003, latest 2022), across 2 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 Sra Developments, Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sra Developments, Ltd. is 92 days.
Which FDA product codes appear under Sra Developments, Ltd.?
The most frequent FDA product codes under this applicant name are LFL (Instrument, Ultrasonic Surgical, 4); JDX (Instrument, Surgical, Sonic And Accessory/Attachment, 1).
Next steps
- See all 5 Sra Developments, Ltd. clearances with predicates and recalls
- Run predicate analysis for product code LFL, Sra Developments, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.