Atomic Products Corp.: FDA clearances and approvals
Atomic Products Corp. has 10 FDA 510(k) clearances (first 1979, latest 1992), across 9 product codes in 2 review panels. Median 510(k) review time: 76 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 |
|---|---|---|---|
| IXQ | Table, Radiographic, Stationary Top | 2 | 2 |
| DXT | Injector And Syringe, Angiographic | 1 | 1 |
| FPO | Stretcher, Wheeled | 1 | 1 |
| IYT | System, Rebreathing, Radionuclide | 1 | 1 |
| IYW | Scanner, Rectilinear, Nuclear | 1 | 1 |
| IYZ | Bed, Scanning, Nuclear | 1 | 1 |
| IZD | Probe, Uptake, Nuclear | 1 | 1 |
| KPT | Calibrator, Dose, Radionuclide | 1 | 1 |
| LLZ | System, Image Processing, Radiological | 1 | 1 |
Review panels
- Radiology (8)
- General Hospital (2)
Most recent Atomic Products Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K915541 | SPECT TABLE, MODEL #056-760 | IYZ | 1992-01-17 | 38 |
| K913055 | THYROID UPTAKE SYST/AUTOMLAB 900 MEDI SPEC 187-900 | IZD | 1991-09-06 | 59 |
| K904187 | ECONOMY C-ARM TABLE, MODEL # 056-005 | IXQ | 1990-11-29 | 78 |
| K904623 | RADIOGRAPHIC TRANSPORT, TRAUMA MODEL 056-230, 235 | IXQ | 1990-11-06 | 26 |
| K900851 | DIGITAL IMAGE ENHANCEMENT SYSTEM | LLZ | 1990-05-11 | 78 |
| K895799 | RECTILINEAR SCANNER MODEL #187-270 | IYW | 1990-02-01 | 126 |
| K884312 | ATOMLAB 100, MODEL 086-250 & 200 MODEL 086-270 | KPT | 1989-02-16 | 126 |
| K871868 | VENTI-SCAN II | IYT | 1988-04-11 | 334 |
| K874332 | MRI STRETCHER | FPO | 1988-01-05 | 75 |
| K790835 | DYNAJECT | DXT | 1979-06-22 | 53 |
Recalls
openFDA lists no recalls under a recalling firm named Atomic Products Corp..
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 Atomic Products Corp. have?
Atomic Products Corp. has 10 FDA 510(k) clearances (first 1979, latest 1992), across 9 product codes in 2 review panels.
How long does FDA take to clear Atomic Products Corp.'s 510(k)s?
The median time from FDA receipt to decision across Atomic Products Corp.'s cleared 510(k)s is 76 days.
What devices does Atomic Products Corp. make?
Its most frequent FDA product codes are IXQ (Table, Radiographic, Stationary Top, 2); DXT (Injector And Syringe, Angiographic, 1); FPO (Stretcher, Wheeled, 1).
Has Atomic Products Corp. had device recalls?
openFDA lists no recalls under a recalling firm name matching Atomic Products Corp. Related entities may recall under other names.
Next steps
- See all 10 Atomic Products Corp. clearances with predicates and recalls
- Run predicate analysis for product code IXQ, Atomic Products Corp.'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.