Mick Radio-Nuclear Instruments, Inc.: FDA filings under this applicant name
FDA lists 43 510(k) clearances under the applicant name “Mick Radio-Nuclear Instruments, Inc.” (first 1978, latest 2023), across 9 product codes in 3 review panels. Median 510(k) review time under this name: 80 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 | 88 |
| 2013 | 0 | — |
| 2014 | 0 | — |
| 2015 | 1 | 157 |
| 2016 | 1 | 414 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 30 |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 1 | 223 |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Mick Radio-Nuclear Instruments, Inc. took a median 126 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 116 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JAQ | System, Applicator, Radionuclide, Remote-Controlled | 22 | 22 |
| IWJ | System, Applicator, Radionuclide, Manual | 9 | 9 |
| IYE | Accelerator, Linear, Medical | 5 | 5 |
| FTY | Tape, Measuring, Rulers And Calipers | 1 | 1 |
| IWB | System, Radiation Therapy, Radionuclide | 1 | 1 |
| IYP | Phantom, Anthropomorphic, Nuclear | 1 | 1 |
| JWJ | Prosthesis, Wrist, 3 Part Metal-Plastic-Metal Articulation, Semi-Constrained | 1 | 1 |
| KDC | Instrument, Surgical, Disposable | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (38)
- General and Plastic Surgery (2)
- Orthopedic (1)
Most recent Mick Radio-Nuclear Instruments, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K230155 | Mick Valencia Applicator Set | JAQ | 2023-08-30 | 223 |
| K200221 | CT F/S/D Compatible Applicators (Fletcher), HDR Compatible Tandem and Ovoid Applicators (Henschke), HDR CT Compatible Split Ring Applicator, Segmented Vaginal Applicator, HDR Miami Applicator HDR Brachytherapy Applicator, 2/3 Endometrial Applicator Sets, CT HDR Ring & Tandem Applicator with Rectal Retractor | JAQ | 2020-02-28 | 30 |
| K150979 | CT/MR Compatible M.A.C. Interstitial GYN Template | JAQ | 2016-05-31 | 414 |
| K142597 | Vienna System | JAQ | 2015-02-19 | 157 |
| K122840 | CT HDR TANDEM/RING APPLICATOR WITH RECTAL RETRACTOR MODEL 0407 | JAQ | 2012-12-14 | 88 |
| K063382 | HDR CT COMPATIBLE SPLIT RING APPLICATOR | JAQ | 2006-12-26 | 48 |
| K063381 | CT COMPATIBLE F/S/D APPLICATORS | JAQ | 2006-12-22 | 44 |
| K052351 | HDR IORT SHIELDED APPLICATOR | JAQ | 2005-10-17 | 49 |
| K051423 | MICK HDR INTERSTITIAL IMPLANT ACCESSORIES | JAQ | 2005-07-01 | 30 |
| K040704 | MODIFICATION TO HENSCHKE HDR CERVIX APPLICATOR AND HILARIS/NORI HDR CERVIX APPLICATOR | JAQ | 2004-06-18 | 92 |
33 earlier clearances. See the full list in Caduvo.
Recalls
openFDA lists no recalls under a recalling firm named Mick Radio-Nuclear Instruments, Inc..
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 Mick Radio-Nuclear Instruments, Inc.?
FDA lists 43 510(k) clearances under the applicant name “Mick Radio-Nuclear Instruments, Inc.” (first 1978, latest 2023), across 9 product codes in 3 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 Mick Radio-Nuclear Instruments, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Mick Radio-Nuclear Instruments, Inc. is 80 days.
Which FDA product codes appear under Mick Radio-Nuclear Instruments, Inc.?
The most frequent FDA product codes under this applicant name are JAQ (System, Applicator, Radionuclide, Remote-Controlled, 22); IWJ (System, Applicator, Radionuclide, Manual, 9); IYE (Accelerator, Linear, Medical, 5).
Next steps
- See all 43 Mick Radio-Nuclear Instruments, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JAQ, Mick Radio-Nuclear Instruments, Inc.'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.