Millennium Medical Technologies, Inc.: FDA filings under this applicant name
FDA lists 5 510(k) clearances under the applicant name “Millennium Medical Technologies, Inc.” (first 2002, latest 2017), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 90 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 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 1 | 44 |
| 2018 | 0 | — |
| 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 Millennium Medical Technologies, Inc. took a median 44 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 108 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| HWC | Screw, Fixation, Bone | 2 | 2 |
| KTT | Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component | 1 | 1 |
| MUU | System, Suction, Lipoplasty | 1 | 1 |
| QPB | System, Suction, Lipoplasty For Removal | 1 | 1 |
Review panels
Most recent Millennium Medical Technologies, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K170449 | Autoclavable Suction Jar with Luer Lock extension - 250, 500, 1,000, 2,000 and 3,000 ml, Autoclavable Suction Jar without Luer Lock extension - 1,500 and 2,500 ml, Sterile 1,500 and 2,500 Lids with Conical patient connection 6-10 and overflow protection | MUU | 2017-03-31 | 44 |
| K081039 | LIPO CANNULA | QPB | 2008-07-10 | 90 |
| K031050 | PCW PERCUTANEOUS COMPRESSION WIRE | HWC | 2003-07-14 | 103 |
| K020791 | HBS HEADLESS BONE SCREW | HWC | 2002-06-06 | 87 |
| K012294 | WRISTORE FIXATOR | KTT | 2002-03-04 | 227 |
Recalls
openFDA lists no recalls under a recalling firm named Millennium Medical Technologies, 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.
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.
- Millennium Biomedical, Inc. (5 510(k)s)
- Millennium Dental Technologies, Inc. (5 510(k)s)
- Millennium Company, LLC (1 510(k)s)
- Millennium Dental International, Inc. (1 510(k)s)
- Millennium Devices, Inc. (1 510(k)s)
- Millennium Magnetic Imaging, Inc. (1 510(k)s)
- Millennium Medical Distribution, Inc. (1 510(k)s)
- Millennium Medical Technologies Inc (Dba Cellmyx) (1 510(k)s)
- Millennium Technology Services (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Millennium Medical Technologies, Inc.?
FDA lists 5 510(k) clearances under the applicant name “Millennium Medical Technologies, Inc.” (first 2002, latest 2017), across 4 product codes in 2 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 Millennium Medical Technologies, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Millennium Medical Technologies, Inc. is 90 days.
Which FDA product codes appear under Millennium Medical Technologies, Inc.?
The most frequent FDA product codes under this applicant name are HWC (Screw, Fixation, Bone, 2); KTT (Appliance, Fixation, Nail/Blade/Plate Combination, Multiple Component, 1); MUU (System, Suction, Lipoplasty, 1).
Next steps
- See all 5 Millennium Medical Technologies, Inc. clearances with predicates and recalls
- Run predicate analysis for product code HWC, Millennium Medical Technologies, 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.