Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Sol-Millennium Medical, Inc. — Predicate Candidate Screening
13 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
117 daysmedian FDA review time
279 days90th percentile
13clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253110 | Sol-Glide Safety Needle; Sol-Glide Safety Needle with Syring | Sol-Millennium Medical, Inc. | 2026-06-18 | 267 | 0 |
| K250907 | Sol-Guard TM XtraThin Safety Pull-Button Blood Collection Se | Sol-Millennium Medical, Inc. | 2025-04-30 | 35 | 0 |
| K242291 | SOL-M Luer Lock Syringe (Low Dead Space) w/o Needle, SOL-M S | Sol-Millennium Medical, Inc. | 2024-11-20 | 110 | 0 |
| K242099 | Sol-M™ Slip Tip Syringe without Needle, Sol-M™ Eccentric Tip | Sol-Millennium Medical, Inc. | 2024-10-22 | 96 | 0 |
| K241821 | Luer Lock Syringe with Safety Needle; Luer Lock Syringe with | Sol-Millennium Medical, Inc. | 2024-09-20 | 88 | 0 |
| K220713 | Sol-Guard Auto-disable Syringe | Sol-Millennium Medical, Inc. | 2023-05-04 | 419 | 0 |
| K222744 | Sol-M Luer Lock Syringe | Sol-Millennium Medical, Inc. | 2022-10-11 | 29 | 0 |
| K213718 | SOL-GUARD Safety Pull Button Collection Set | Sol-Millennium Medical, Inc. | 2022-08-30 | 279 | 0 |
| K182146 | Sol-M Blood Collection Needles, Sol-Care Safety Blood Collec | Sol-Millennium Medical, Inc. | 2018-12-03 | 117 | 0 |
| K163073 | Sol-Care Safety Blood Collection Needle with and without Pre | Sol-Millennium Medical, Inc. | 2017-05-19 | 198 | 0 |
| K162030 | 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle | Sol-Millennium Medical, Inc. | 2016-08-19 | 28 | 0 |
| K153537 | Sol-M Insulin Syringe, Sol-M TB Syringe | Sol-Millennium Medical, Inc. | 2016-06-17 | 190 | 0 |
| K132681 | SOL-GUARD INSULIN AND TUBERCULIN SAFETY SYRINGE | Sol-Millennium Medical, Inc. | 2014-05-22 | 267 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda