Micron Corp.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Micron Corp.” (first 1999, latest 2018), across 2 product codes in 1 review panel. Median 510(k) review time under this name: 189 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 | 0 | — |
| 2013 | 0 | — |
| 2014 | 1 | 162 |
| 2015 | 0 | — |
| 2016 | 1 | 191 |
| 2017 | 0 | — |
| 2018 | 1 | 323 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Micron Corp. took a median 323 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 248 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| ELC | Scaler, Ultrasonic | 4 | 4 |
| EFB | Handpiece, Air-Powered, Dental | 1 | 1 |
Review panels
- Dental (5)
Most recent Micron Corp. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K171150 | AW-100 | ELC | 2018-03-08 | 323 |
| K161639 | Y-MIC | ELC | 2016-12-22 | 191 |
| K133170 | QUICK JET M | EFB | 2014-03-28 | 162 |
| K032995 | SSS, MODEL 1072001 (STANDARD 4-HOLE MODEL) & 1072002 (STANDARD 2-HOLE MODEL) | ELC | 2003-11-20 | 56 |
| K991239 | VIP 60 (2H), MODEL 115-000-1, VIP 60 (4H), MODEL 115-000-2 | ELC | 1999-10-18 | 189 |
Recalls
openFDA lists no recalls under a recalling firm named Micron Corp..
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.
Other FDA applicant names starting with the same word
FDA records these as separate applicants. Some may belong to the same corporate group and some may not; their filings are not included in the counts above.
- Micron Instruments, Inc. (3 510(k)s)
- Micron Metal & Plastic Manufactory Co. (2 510(k)s)
- Micron Precision Engineering, Inc. (2 510(k)s)
- Micron Technology, Inc. (2 510(k)s)
- Micron Eyewear Manufactory Co., Ltd. (1 510(k)s)
- Micron Medical Corporation (1 510(k)s)
- Micron Surgical, Inc. (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Micron Corp.?
FDA lists 5 510(k) clearances under the applicant name “Micron Corp.” (first 1999, latest 2018), across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Micron Corp.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Micron Corp. is 189 days.
Which FDA product codes appear under Micron Corp.?
The most frequent FDA product codes under this applicant name are ELC (Scaler, Ultrasonic, 4); EFB (Handpiece, Air-Powered, Dental, 1).
Next steps
- See all 5 Micron Corp. clearances with predicates and recalls
- Run predicate analysis for product code ELC, Micron 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.