Downs Surgical , Ltd.: FDA filings under this applicant name
FDA lists 60 510(k) clearances under the applicant name “Downs Surgical , Ltd.” (first 1980, latest 1990), across 34 product codes in 9 review panels. Median 510(k) review time under this name: 70 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 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HRX | Arthroscope | 10 | 10 |
| GDM | Needle, Aspiration And Injection, Reusable | 5 | 5 |
| HAO | Instrument, Surgical, Non-Powered | 5 | 5 |
| GZX | Instrument, Microsurgical | 2 | 2 |
| HCI | Applier, Aneurysm Clip | 2 | 2 |
| HDF | Speculum, Vaginal, Metal | 2 | 2 |
| KWA | Prosthesis, Hip, Semi-Constrained (Metal Uncemented Acetabular Component) | 2 | 2 |
| EIG | Retractor, All Types | 1 | 1 |
| EMF | Knife, Surgical | 1 | 1 |
| EMH | Forceps, Rongeur, Surgical | 1 | 1 |
Plus 24 more product codes.
Review panels
- Orthopedic (18)
- General and Plastic Surgery (14)
- Neurology (11)
- Ear, Nose and Throat (3)
- Dental (2)
- Obstetrics and Gynecology (2)
- Radiology (2)
- General Hospital (1)
- Ophthalmic (1)
Most recent Downs Surgical , Ltd. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K903750 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-598-OO-E | GDM | 1990-10-31 | 76 |
| K903749 | ISLAM STERNAL PUNCTURE NEEDLE, CAT #AG-596-00-U | GDM | 1990-10-31 | 76 |
| K903748 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AF-594-00-V | GDM | 1990-10-31 | 76 |
| K903747 | ISLAM STERNAL PUNCTURE NEEDLE, CAT # AG-592-00-U | GDM | 1990-10-31 | 76 |
| K900616 | SHEPPERD CUTTING FORCEPS | HRX | 1990-10-22 | 256 |
| K900615 | SHEPPERD NERVE ROOT RETRACTOR W/SUCTION & FIBRE | HRX | 1990-10-22 | 256 |
| K900614 | SHEPPERD SHORT MUSCLE RETRACTOR (GS-501-45-V) | HRX | 1990-10-22 | 256 |
| K900613 | SHEPPERD SHELTER TUBE COMPLETE & DRILL | HRX | 1990-10-22 | 256 |
| K900612 | SHEPPERD TREPHINE SET (GS-501-30-V) | HRX | 1990-10-22 | 256 |
| K900611 | SHEPPERD DILATATION TUBE SET (GS-501-20-H) | HRX | 1990-10-22 | 256 |
50 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Downs Surgical , 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 Downs Surgical , Ltd.?
FDA lists 60 510(k) clearances under the applicant name “Downs Surgical , Ltd.” (first 1980, latest 1990), across 34 product codes in 9 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 Downs Surgical , Ltd.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Downs Surgical , Ltd. is 70 days.
Which FDA product codes appear under Downs Surgical , Ltd.?
The most frequent FDA product codes under this applicant name are HRX (Arthroscope, 10); GDM (Needle, Aspiration And Injection, Reusable, 5); HAO (Instrument, Surgical, Non-Powered, 5).
Next steps
- See all 60 Downs Surgical , Ltd. clearances with predicates and recalls
- Run predicate analysis for product code HRX, Downs Surgical , 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.