Wfr/Aquaplast Corp.: FDA filings under this applicant name
FDA lists 8 510(k) clearances under the applicant name “Wfr/Aquaplast Corp.” (first 1994, latest 2012), across 5 product codes in 4 review panels. Median 510(k) review time under this name: 85 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 | 1 | 85 |
| 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 3 | 3 |
| JAI | Couch, Radiation Therapy, Powered | 2 | 2 |
| EMA | Cement, Dental | 1 | 1 |
| EPP | Splint, Nasal | 1 | 1 |
| LZM | Guard, Skin Graft | 1 | 1 |
Review panels
- Radiology (5)
- Dental (1)
- Ear, Nose and Throat (1)
- General and Plastic Surgery (1)
Most recent Wfr/Aquaplast Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K120916 | QFIX RADIOTHERAPY CHAIR | JAI | 2012-06-20 | 85 |
| K060671 | KVUE IGRT TREATMENT TABLE TOP, RT-4551KV, KVUE INSERTS AND ACCESSORIES, VARIOUS | JAI | 2006-05-04 | 51 |
| K032156 | ACCUFIX RADIOLUCENT PELVIS AND BELLY BOARDS, ACCUFIX CANTILEVER HEAD BOARD WITH SHOULDER DEPRESSION, ACCUFIX RADIOLUCENT | IYE | 2003-09-02 | 50 |
| K021124 | ACCUFIX TILTING RADIOTRANSLUCENT HEADHOLDER | IYE | 2002-07-02 | 85 |
| K973370 | AQUAPLAST PALATAL STENT | EMA | 1997-12-02 | 85 |
| K943871 | AQUAPLAST TIE DOWN DRESSING | LZM | 1994-09-30 | 53 |
| K942158 | AQUAPLAST NASAL SPLINTS, PRECUT SILVER SPLINT PATTERNS AND SPLINT KITS | EPP | 1994-07-29 | 87 |
| K935067 | AQUAPLAST | IYE | 1994-05-26 | 218 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2016-01-07.
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 Wfr/Aquaplast Corp.?
FDA lists 8 510(k) clearances under the applicant name “Wfr/Aquaplast Corp.” (first 1994, latest 2012), across 5 product codes in 4 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 Wfr/Aquaplast Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Wfr/Aquaplast Corp. is 85 days.
Which FDA product codes appear under Wfr/Aquaplast Corp.?
The most frequent FDA product codes under this applicant name are IYE (Accelerator, Linear, Medical, 3); JAI (Couch, Radiation Therapy, Powered, 2); EMA (Cement, Dental, 1).
Next steps
- See all 8 Wfr/Aquaplast Corp. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Wfr/Aquaplast Corp.'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.