Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MEG — Predicate Candidate Screening
162 FDA 510(k) clearances under this product code; the 50 most recent screened below.
128 daysmedian FDA review time
349 days90th percentile
162clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K252098 | PA3X Detachable Safety Sleeve Syringe (with needle) (SC-23ED | Methyl Co., Ltd. | 2026-02-18 | 230 | 0 |
| K250847 | VaporShield | Vault Paragon Group, Inc. | 2025-12-12 | 267 | 0 |
| K230287 | SaviSafe Safety Device | Suzhou Savicred Biotechnology Co., Ltd. | 2023-11-21 | 292 | 0 |
| K231165 | Shina Syringe; Shina Safety Syringe | Shina Med Corporation | 2023-10-27 | 185 | 0 |
| K231907 | Medline Safety Insulin and TB Syringes | Medline Industries, LP | 2023-10-18 | 111 | 0 |
| K223376 | Monoject Magellan Insulin Safety Syringe 1mL, 31G x 6mm (888 | Cardinal Health200, LLC | 2023-06-21 | 229 | 0 |
| K220114 | PowerPAK Syringe | Vault Paragon Group, Inc. | 2023-01-25 | 376 | 0 |
| K221981 | SafeR Syringe and SafeR Sting | Roncadelle Operations Srl | 2022-12-29 | 177 | 0 |
| K222452 | Disposable Automatically Retractable Safety Syringes (with d | Shantou Wealy Medical Instrument Co.,Ltd | 2022-11-23 | 100 | 0 |
| K221247 | Sterile Disposable Syringe with Safety Needle, Sterile Dispo | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2022-11-01 | 183 | 0 |
| K220057 | Disposable Sterile Syringe with permanently attached needle; | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-10-07 | 274 | 0 |
| K221073 | Sterile Hypodermic Syringes for Single Use with Safety Needl | Sichuan Prius Biotechnology Co., Ltd. | 2022-10-04 | 175 | 0 |
| K220061 | Safety Insulin Syringes | Berpu Medical Technology Co., Ltd. | 2022-08-23 | 225 | 0 |
| K212518 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | 2022-08-18 | 373 | 0 |
| K213077 | Automatically Retractable Safety Syringe | Zhejiang Lingyang Medical Apparatus Co., Ltd. | 2022-04-27 | 216 | 0 |
| K210216 | Disposable Automatically Retractable Insulin Safety Syringe | Shantou Wealy Medical Instrument Co.,Ltd | 2022-03-04 | 401 | 0 |
| K212652 | Sterile Syringe with Fixed Safety Needle for Single Use | Gemtier Medical (Shanghai), Inc. | 2022-03-02 | 191 | 0 |
| K211484 | Disposable Sterile Syringe with Safety Needle; Disposable St | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022-03-01 | 293 | 0 |
| K212949 | Sterile Syringe with Safety Needle for Single Use, Sterile S | Henan Nursecare Biotechnology Co., Ltd. | 2022-02-24 | 161 | 0 |
| K210229 | Sterile Auto-Disable Syringes with/without Needle for Single | Zhejiang Kangkang Medical-Devices Co., Ltd. | 2022-02-15 | 383 | 0 |
| K211329 | Sterile Disposable Syringe with Saftey Needle, Sterile Dispo | Jiangsu Kangbao Medical Equipment Co., Ltd. | 2021-11-15 | 196 | 0 |
| K211555 | Hypodermic Safety Needle; Hypodermic Safety Needle with Syri | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2021-10-18 | 152 | 0 |
| K211753 | Sterile Syringe With Safety Needle | Jiangxi Hongda Medical Equipment Group , Ltd. | 2021-10-14 | 129 | 0 |
| K212226 | DR Safety Syringe, Sterile Hypodermic needle for Single use | Zhuhai DR Medical Instruments Co., Ltd. | 2021-09-29 | 75 | 0 |
| K202570 | Insulin Syringe, Insulin Syringe with Safety Retractable | Jiangsu Micsafe Medical Technology Co., Ltd. | 2021-07-02 | 301 | 0 |
| K191639 | TK Insulin Syringe with/without Saftey Retractable Device | Anhui Tiankang Medical Technology Co., Ltd. | 2020-09-11 | 450 | 0 |
| K193022 | Retractable Safety Insulin Syringe | Jiangsu Caina Medical Co.,Ltd | 2020-07-20 | 264 | 0 |
| K192679 | Sterile Syringe with Safety needle for Single Use, Sterile S | Gemtier Medical (Shanghai), Inc. | 2020-04-10 | 197 | 0 |
| K190183 | Hypodermic Safety Needle, Hypodermic Safety Needle with Syri | Anhui Hongyu Wuzhou Medical Manufacturer Co., Ltd. | 2019-10-04 | 245 | 0 |
| K191490 | Retractable Safety Syringe, Retractable Safety Insulin Syrin | Jiangsu Caina Medical Co.,Ltd | 2019-10-03 | 120 | 0 |
| K183665 | Safety Needles, Sterile Syringe, Sterile Syringe with Safety | Jiangsu Micsafe Medical Technology Co., Ltd. | 2019-09-06 | 253 | 0 |
| K173743 | Greenmedi Safety Filter Syringe | Sang-A Frontec Co., Ltd. | 2019-01-28 | 417 | 0 |
| K180417 | Self-destruction Safety Syringes for Single Use; Sterile Hyp | Berpu Medical Technology Co., Ltd. | 2018-08-09 | 175 | 0 |
| K170651 | Sterile Disposable Syringe with Safety Needle, Sterile Dispo | Yangzhou Medline Industry, Co., Ltd. | 2017-08-02 | 152 | 0 |
| K163162 | Sterile Hypodermic Safety Syringes for Single Use | Jiangxi Hongda Medical Equipment Group , Ltd. | 2017-03-20 | 130 | 0 |
| K163511 | NovaGuard SA Pro Safety System | West Pharmaceutical Services, Inc. | 2017-02-02 | 49 | 0 |
| K162030 | 0.5ml Sol-Care Retractable Safety Syringe with Fixed Needle | Sol-Millennium Medical, Inc. | 2016-08-19 | 28 | 0 |
| K152606 | Jeesung Safety Syringe and Single Use Needles | Jeesung Medical Co., Ltd. | 2016-06-28 | 291 | 0 |
| K152808 | U&U Insulin Syringe with/without Safety Retractable Device | U&U Medical Technology Co, Ltd. | 2016-03-25 | 179 | 0 |
| K143497 | Safety Auto-Disable Syrine with Needle (Auto-Lock) | Guangdong Intmed Medical Appliance Co., Ltd. | 2015-11-04 | 330 | 0 |
| K143070 | Disposable Safety Self-destructive Syringes, 5 ML | Jiangsu Yile Medical Article Co., Ltd. | 2015-07-07 | 253 | 0 |
| K150562 | Safe'n'Sound Staked Passive Delivery System - Plajex version | Nemera | 2015-06-02 | 88 | 0 |
| K141349 | Disposable sterile needle retractable safety syringe | Guangdong Haiou Medical Apparatus Stock Co., Ltd. | 2015-04-10 | 323 | 0 |
| K142435 | 3S Safety Syringe with/without Needle | Sincere Medical Device Co., Ltd. | 2015-02-20 | 175 | 0 |
| K142436 | 3S Safety Insulin Syringe | Sincere Medical Device Co., Ltd. | 2015-02-19 | 174 | 0 |
| K140949 | ULTICARE SAFETY SYRINGE WITH REMOVABLE NEEDLE | Ultimed Incorporated | 2015-02-09 | 301 | 0 |
| K141640 | AUTOMATICALLY RETRACTABLE SAFETY SYRINGES WITH FIXED NEEDLE | Shantou Wealy Medical Instrument Co.,Ltd | 2014-11-19 | 153 | 0 |
| K141664 | SAFE'N'SOUND STAKED PASSIVE DELIVERY SYSTEM - CONE VERSION | Rexam Healthcare | 2014-10-02 | 101 | 0 |
| K141464 | NOVAGUARD S A SAFETY SYSTEM | West Pharmaceutical Services | 2014-09-10 | 99 | 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