Cuda Products Co.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Cuda Products Co.” (first 1988, latest 1998), across 12 product codes in 5 review panels. Median 510(k) review time under this name: 75 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 |
|---|---|---|---|
| FSS | Light, Surgical, Floor Standing | 3 | 3 |
| FST | Light, Surgical, Fiberoptic | 3 | 3 |
| HET | Laparoscope, Gynecologic (And Accessories) | 2 | 2 |
| EBA | Light, Surgical Headlight | 1 | 1 |
| EIA | Unit, Operative Dental | 1 | 1 |
| ERA | Otoscope | 1 | 1 |
| FCW | Light Source, Fiberoptic, Routine | 1 | 1 |
| FSW | Light, Surgical, Endoscopic | 1 | 1 |
| GCJ | Laparoscope, General & Plastic Surgery | 1 | 1 |
| GDB | Endoscope, Fiber Optic | 1 | 1 |
Plus 2 more product codes.
Review panels
- General and Plastic Surgery (10)
- Dental (2)
- Gastroenterology and Urology (2)
- Obstetrics and Gynecology (2)
- Ear, Nose and Throat (1)
Most recent Cuda Products Co. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K983277 | LIGHTSOURCE OR ILLUMINATOR MODEL I-100 | HBI | 1998-12-16 | 90 |
| K981962 | CUDA PRODUCTS CORP. MODEL M300 (M-300) LIGHTSOURCE | FSS | 1998-08-18 | 75 |
| K981469 | CERMAX300 LIGHTSOURCE | FSS | 1998-07-09 | 77 |
| K980350 | VIDEO CAMERA/LIGHTSOURCE COMBINATION UNIT MODEL VCL-150 | GCJ | 1998-04-28 | 90 |
| K980166 | LIGHTSOURCE OR ILLUMINATOR | HET | 1998-04-01 | 75 |
| K961074 | LIGHTSOURCE OR ILLUMINATOR | FSS | 1996-04-30 | 43 |
| K951019 | INTRAORAL VIDEO SCOPE AND WINDOW TUBE | EIA | 1995-05-10 | 64 |
| K943731 | VIDEO OTOSCOPE | ERA | 1994-10-11 | 70 |
| K935818 | ENDOSCOPE | GDB | 1994-07-13 | 223 |
| K933369 | CUDA PRODUCTS CORP. LIGHTSOURCES | FCW | 1994-01-03 | 178 |
7 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Cuda Products Co..
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 Cuda Products Co.?
FDA lists 17 510(k) clearances under the applicant name “Cuda Products Co.” (first 1988, latest 1998), across 12 product codes in 5 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 Cuda Products Co.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Cuda Products Co. is 75 days.
Which FDA product codes appear under Cuda Products Co.?
The most frequent FDA product codes under this applicant name are FSS (Light, Surgical, Floor Standing, 3); FST (Light, Surgical, Fiberoptic, 3); HET (Laparoscope, Gynecologic (And Accessories), 2).
Next steps
- See all 17 Cuda Products Co. clearances with predicates and recalls
- Run predicate analysis for product code FSS, Cuda Products Co.'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.