Sol-Millennium Medical, Inc.: FDA filings under this applicant name
FDA lists 15 510(k) clearances under the applicant name “Sol-Millennium Medical, Inc.” (first 2013, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 159 days. Since 2017 the median was 117 days, against 175 days for all cleared 510(k)s in the same product codes. 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 |
|---|---|---|
| 2013 | 1 | 159 |
| 2014 | 1 | 267 |
| 2015 | 0 | — |
| 2016 | 2 | 109 |
| 2017 | 1 | 198 |
| 2018 | 1 | 117 |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 2 | 154 |
| 2023 | 1 | 419 |
| 2024 | 3 | 96 |
| 2025 | 1 | 35 |
| 2026 | 2 | 338 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Sol-Millennium Medical, Inc. took a median 117 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 175 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| FMF | Syringe, Piston | 7 | 7 |
| JKA | Tubes, Vials, Systems, Serum Separators, Blood Collection | 3 | 3 |
| FMI | Needle, Hypodermic, Single Lumen | 2 | 2 |
| MEG | Syringe, Antistick | 2 | 2 |
| QNQ | Low Dead Space Piston Syringe | 1 | 1 |
Review panels
- General Hospital (12)
- Clinical Chemistry (3)
Most recent Sol-Millennium Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K252184 | SOL-M Luer Lock Syringe with Exchangeable Needle Tray | FMF | 2026-08-25 | 410 |
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syringe | FMF | 2026-06-18 | 267 |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Set | JKA | 2025-04-30 | 35 |
| K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/o needle, SOL-M Luer Lock Syringe (Low Dead Space) w/Exchangeable Needle, SOL-CARE Luer Lock Syringe (Low Dead Space) w/Safety Needle, SOL-M Slip Tip Syringe (Low Dead Space) w/Exchangeable Needle | QNQ | 2024-11-20 | 110 |
| K242099 | Sol-M Slip Tip Syringe without Needle, Sol-M Eccentric Tip Syringe without Needle | FMF | 2024-10-22 | 96 |
| K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with Exchangeable Needle; Luer Lock Syringe with Blunt Fill Needle | FMF | 2024-09-20 | 88 |
| K220713 | Sol-Guard Auto-disable Syringe | FMF | 2023-05-04 | 419 |
| K222744 | Sol-M Luer Lock Syringe | FMF | 2022-10-11 | 29 |
| K213718 | SOL-GUARD Safety Pull Button Collection Set | JKA | 2022-08-30 | 279 |
| K182146 | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collection Needles, Sol-Care Safety Blood Collection Needle with Holders, Sol-M Blood Collection Set | FMI | 2018-12-03 | 117 |
5 earlier clearances. See the full list in Caduvo.
Recalls
6 product recalls in 1 recall events; 6 initiated in the last five years. Most recent: 2024-05-09.
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.
- Sol-Millennium Medical Group (1 510(k)s)
Frequently asked questions
How many FDA 510(k) clearances are listed under Sol-Millennium Medical, Inc.?
FDA lists 15 510(k) clearances under the applicant name “Sol-Millennium Medical, Inc.” (first 2013, latest 2026), across 5 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 Sol-Millennium Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Sol-Millennium Medical, Inc. is 159 days. Since 2017: 117 days, versus 175 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Sol-Millennium Medical, Inc.?
The most frequent FDA product codes under this applicant name are FMF (Syringe, Piston, 7); JKA (Tubes, Vials, Systems, Serum Separators, Blood Collection, 3); FMI (Needle, Hypodermic, Single Lumen, 2).
Next steps
- See all 15 Sol-Millennium Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code FMF, Sol-Millennium Medical, 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.