Advanced Instrument Development, Inc.: FDA clearances and approvals
Advanced Instrument Development, Inc. has 5 FDA 510(k) clearances (first 1979, latest 1998), across 4 product codes in 1 review panel. Median 510(k) review time: 47 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 |
|---|---|---|---|
| IZO | Generator, High-Voltage, X-Ray, Diagnostic | 2 | 2 |
| IZL | System, X-Ray, Mobile | 1 | 1 |
| KPR | System, X-Ray, Stationary | 1 | 1 |
Plus 1 more product codes.
Review panels
- Radiology (4)
Most recent Advanced Instrument Development, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K974863 | IMIX DIGITAL THORAX SYSTEM | KPR | 1998-03-17 | 78 |
| K872445 | POWER-AID INDEPENDENT X-RAY POWER SOURCE | IZO | 1987-08-12 | 50 |
| K827525 | AUTOMATIC EXPOSURE CONTROL TYPE A3300 | — | 1982-06-18 | 28 |
| K813128 | MOBIL-AID AUTOMATIC EXPOSURE CONTROL | IZL | 1981-12-03 | 28 |
| K791933 | CONVERSION CONTRACTOR TIMER KIT | IZO | 1979-11-13 | 47 |
Recalls
openFDA lists no recalls under a recalling firm named Advanced Instrument Development, 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 Advanced Instrument Development, Inc. have?
Advanced Instrument Development, Inc. has 5 FDA 510(k) clearances (first 1979, latest 1998), across 4 product codes in 1 review panel.
How long does FDA take to clear Advanced Instrument Development, Inc.'s 510(k)s?
The median time from FDA receipt to decision across Advanced Instrument Development, Inc.'s cleared 510(k)s is 47 days.
What devices does Advanced Instrument Development, Inc. make?
Its most frequent FDA product codes are IZO (Generator, High-Voltage, X-Ray, Diagnostic, 2); IZL (System, X-Ray, Mobile, 1); KPR (System, X-Ray, Stationary, 1).
Has Advanced Instrument Development, Inc. had device recalls?
openFDA lists no recalls under a recalling firm name matching Advanced Instrument Development, Inc. Related entities may recall under other names.
Next steps
- See all 5 Advanced Instrument Development, Inc. clearances with predicates and recalls
- Run predicate analysis for product code IZO, Advanced Instrument Development, 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.