Contour Fabricators of Florida, Inc.: FDA clearances and approvals
Contour Fabricators of Florida, Inc. has 18 FDA 510(k) clearances (first 1993, latest 1996), across 12 product codes in 7 review panels. Median 510(k) review time: 85 days.
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 |
|---|---|---|---|
| FRG | Wrap, Sterilization | 4 | 4 |
| BSY | Catheters, Suction, Tracheobronchial | 2 | 2 |
| DXT | Injector And Syringe, Angiographic | 2 | 2 |
| KYZ | Syringe, Irrigating (Non Dental) | 2 | 2 |
| DWS | Instruments, Surgical, Cardiovascular | 1 | 1 |
| FMF | Syringe, Piston | 1 | 1 |
| FMI | Needle, Hypodermic, Single Lumen | 1 | 1 |
| HIO | Sampler, Amniotic Fluid (Amniocentesis Tray) | 1 | 1 |
| JAA | System, X-Ray, Fluoroscopic, Image-Intensified | 1 | 1 |
| KNY | Accessories, Catheter, G-U | 1 | 1 |
Plus 2 more product codes.
Review panels
- General Hospital (10)
- Anesthesiology (2)
- General and Plastic Surgery (2)
- Cardiovascular (1)
- Gastroenterology and Urology (1)
- Obstetrics and Gynecology (1)
- Radiology (1)
Most recent Contour Fabricators of Florida, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K955685 | RNS STERILE, DISPOSABLE CT BIOPSY TRAY | DXT | 1996-10-04 | 295 |
| K962040 | RNS ARTHROGRAM TRAY | FMI | 1996-06-25 | 32 |
| K955687 | RNS STERILE, DISPOSABLE RADIOGRAPHIC CONTRAST TRAY | JAA | 1996-06-03 | 172 |
| K955689 | RNS STERILE, DISPOSABLE DIGITAL ANGIOGRAPHIC TRAY | DWS | 1996-05-15 | 153 |
| K955684 | RNS STERILE, DISPOSABLE ANGIOGRAPHIC TRAY | DXT | 1996-05-02 | 140 |
| K955679 | RNS STERILE, DISPOSABLE AMNIOCENTESIS TRAY | HIO | 1996-03-12 | 89 |
| K955688 | RNS STERILE, DISPOSABLE STANDARD BIOPSY TRAY | FRG | 1996-02-21 | 69 |
| K955686 | RNS, STERILE DISPOSABLE PERCUTANEOUS CHOLANGIOGRAPHIC TRAY | FRG | 1996-02-21 | 69 |
| K955678 | RNS STERILE DISPOSABLE PUNCTURE TRAY | FRG | 1996-02-21 | 69 |
| K955683 | RNS STERILE, DISPOSABLE BREAST BIOPSY/LOCALIZATION TRAY | MJG | 1996-02-01 | 49 |
8 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Contour Fabricators of Florida, Inc..
Recalling firms are matched to this company by name only (same normalization as the applicant), so related entities that recall under another name are not counted.
Frequently asked questions
How many FDA 510(k) clearances does Contour Fabricators of Florida, Inc. have?
Contour Fabricators of Florida, Inc. has 18 FDA 510(k) clearances (first 1993, latest 1996), across 12 product codes in 7 review panels.
How long does FDA take to clear Contour Fabricators of Florida, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Contour Fabricators of Florida, Inc.'s cleared 510(k)s is 85 days.
What devices does Contour Fabricators of Florida, Inc. make?
Its most frequent FDA product codes are FRG (Wrap, Sterilization, 4); BSY (Catheters, Suction, Tracheobronchial, 2); DXT (Injector And Syringe, Angiographic, 2).
Has Contour Fabricators of Florida, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Contour Fabricators of Florida, Inc. Related entities may recall under other names.
Next steps
- See all 18 Contour Fabricators of Florida, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FRG, Contour Fabricators of Florida, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Companies are grouped by FDA applicant name with punctuation and legal suffixes removed. Review days run from FDA receipt to decision. Not regulatory advice.