Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
QNQ — Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
194 daysmedian FDA review time
445 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252814 | Profoject™ Low Dead Space Syringe /Profoject™ Tuberculin Syr | CMT Health PTE., Ltd. | 2026-02-19 | 168 | 0 |
| K250127 | TSK Syringe | Tsk Laboratory, Japan | 2025-07-30 | 194 | 0 |
| K250138 | Small Volume 0.2mL Syringe | Prosum Medical Limited | 2025-04-02 | 75 | 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 |
| K232943 | Hypodermic Needle-Pro® EDGE™ Safety Device with Low Dead Spa | Smiths Medical Asd, Inc. | 2024-05-31 | 254 | 0 |
| K241190 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe; PLP | Poonglim Pharmatech, Inc. | 2024-05-29 | 30 | 0 |
| K231856 | TopFine® LDS (Low Dead Space) Syringe (2 models (TS-LDS2334, | Medexel Co.,Ltd | 2024-03-15 | 266 | 0 |
| K221860 | PLPT LDV(Low Dead Volume) LC(Luer-Cone) Sterile Syringe, PLP | Poonglim Pharmatech, Inc. | 2023-09-15 | 445 | 0 |
| K213010 | FEELject LDV (Low dead volume) syringe | Feeltech Co., Ltd. | 2023-05-31 | 618 | 0 |
| K213013 | Sterile Single-use LDV Syringe, CHOICARE Sterile Single-use | Jeil Tech Co., Ltd. | 2022-09-19 | 364 | 0 |
| K220083 | LDV((Low Dead Volume )Syringe | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2022-05-25 | 135 | 0 |
| K210443 | PLPT LDV (Low Dead Volume) Sterile Syringe | Poonglim Pharmatech, Inc. | 2021-02-16 | 0 | 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