Victoreen, Inc.: FDA clearances and approvals
Victoreen, Inc. has 40 FDA 510(k) clearances (first 1979, latest 1998), across 25 product codes in 2 review panels. Median 510(k) review time: 81 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 |
|---|---|---|---|
| IYE | Accelerator, Linear, Medical | 5 | 5 |
| KPR | System, X-Ray, Stationary | 4 | 4 |
| EAK | Screen, Leaded, Operator Radiation Protector | 3 | 3 |
| KPQ | System, Simulation, Radiation Therapy | 3 | 3 |
| LHO | Instrument, Quality-Assurance, Radiologic | 3 | 3 |
| KPT | Calibrator, Dose, Radionuclide | 2 | 2 |
| LHN | System, Radiation Therapy, Charged-Particle, Medical | 2 | 2 |
| ISD | Exerciser, Measuring | 1 | 1 |
| ITX | Transducer, Ultrasonic, Diagnostic | 1 | 1 |
| ITY | Assembly, Tube Housing, X-Ray, Diagnostic | 1 | 1 |
Plus 15 more product codes.
Review panels
- Radiology (37)
- Physical Medicine (1)
Most recent Victoreen, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K982937 | MODEL 580-006 RADIATION THERAPY IONIZATION CHAMBER | LHN | 1998-11-19 | 90 |
| K974112 | VACUDAP, MODEL 2000, 2001 | KPR | 1998-01-29 | 90 |
| K973960 | MODEL 37-185 | LHN | 1998-01-14 | 90 |
| K964952 | VERIDOSE V (FIVE), MODEL NUMBER 37-705 | JAD | 1997-07-21 | 223 |
| K964785 | VERIDOSE DIODES | IYE | 1997-06-13 | 196 |
| K971382 | PRONE BREAST POSITIONING BOARD, MODEL #37-018 | IYE | 1997-06-06 | 84 |
| K952233 | CLEAR-PB LEAD PLASTIC OVERHEAD BARRIER 56-628 | EAK | 1995-06-16 | 35 |
| K940660 | MODEL 37-720 DUAL DIODE DOSIMETRY SYSTEM | IYE | 1994-12-09 | 297 |
| K935435 | NUCLEAR ASSOC 37-08 SER, RAYCAST HP RADIO IMMOB SYST | IYE | 1994-07-29 | 261 |
| K941931 | DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR | KPR | 1994-05-26 | 36 |
30 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Victoreen, 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 Victoreen, Inc. have?
Victoreen, Inc. has 40 FDA 510(k) clearances (first 1979, latest 1998), across 25 product codes in 2 review panels.
How long does FDA take to clear Victoreen, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Victoreen, Inc.'s cleared 510(k)s is 81 days.
What devices does Victoreen, Inc. make?
Its most frequent FDA product codes are IYE (Accelerator, Linear, Medical, 5); KPR (System, X-Ray, Stationary, 4); EAK (Screen, Leaded, Operator Radiation Protector, 3).
Has Victoreen, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Victoreen, Inc. Related entities may recall under other names.
Next steps
- See all 40 Victoreen, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IYE, Victoreen, 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.