Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MMK — Predicate Candidate Screening
114 FDA 510(k) clearances under this product code; the 50 most recent screened below.
92 daysmedian FDA review time
266 days90th percentile
114clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260845 | Huahong Sharps Container (HHR-I, HHR-II) | Tianjin Huahong Technology Co., Ltd. | 2026-08-05 | 142 | 0 |
| K253773 | Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Contain | Taizhou Huangyan Guanhong Plastic Steel Products Factory | 2026-05-22 | 177 | 0 |
| K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Zhejiang Gongdong Medical Technology Co., Ltd. | 2025-12-22 | 84 | 0 |
| K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, | Pureway Compliance, Inc. | 2025-10-14 | 118 | 0 |
| K252637 | Community Containers (Flap and Daisy) | Keter Canada, Inc. | 2025-10-14 | 55 | 0 |
| K231484 | PureWay 1.4 Quart Sharps Collector | Pureway Compliance, Inc. | 2023-09-14 | 114 | 0 |
| K222906 | Maxcon Reusable Sharps Container, 17 Gallon Sharps Container | Ningbo Maxcon Medical Technology Co., Ltd. | 2023-06-16 | 266 | 0 |
| K222905 | Maxcon Sharps Container (1 QT Sharps Container, MA1112), Max | Ningbo Maxcon Medical Technology Co., Ltd. | 2023-06-01 | 251 | 0 |
| K213274 | Qlicksmart BladeFlask UNIVERSAL | Qlicksmart Pty , Ltd. | 2022-06-22 | 265 | 0 |
| K211890 | Promisemed Sharps container | Promisemed Hangzhou Meditech Co., Ltd. | 2021-11-17 | 149 | 0 |
| K211464 | Nitta M&T Safety Box | Nitta M&T (Thailand) Co., Ltd. | 2021-09-14 | 126 | 0 |
| K203305 | Tiger Reusable Sharps Container | International Marketing Specialists, Inc. | 2021-08-06 | 270 | 0 |
| K201523 | Sharps container | Zhejiang Gongdong Medical Technology Co., Ltd. | 2020-11-12 | 157 | 0 |
| K190240 | Tiger Sharps Containers | International Marketing Specialists, Inc. | 2019-05-31 | 114 | 0 |
| K182235 | OnSite Waste Sharps Container | Bluestone Medical, Inc. | 2019-05-20 | 276 | 0 |
| K180984 | Maxcon Sharps Container | Ningbo Maxcon Medical Technology Co., Ltd. | 2019-01-03 | 265 | 0 |
| K180983 | Maxcon Two Gallon Chemotherapy Container | Ningbo Maxcon Medical Technology Co., Ltd. | 2019-01-03 | 265 | 0 |
| K172719 | HealthBeacon HB2 Sharps Bin | Healthbeacon, Ltd. | 2018-05-11 | 245 | 0 |
| K170513 | MAUSER PG II Sharps Container | Mauzer USA, LLC | 2017-11-01 | 253 | 0 |
| K153274 | Med-Tainer Single Deposit Container | Snyder Industries, Inc. | 2016-08-04 | 266 | 0 |
| K153363 | Red2Green Reusable Sharps Container | Triumvirate Environmental, Inc. | 2016-07-26 | 249 | 0 |
| K161180 | Oak Ridge Products Sharps Containers | Oak Ridge Products, LLC | 2016-06-09 | 43 | 0 |
| K152340 | NAR Sharps Shuttle; NAR Sharps Shuttle Pack of six | North American Rescue, LLC | 2016-05-31 | 286 | 0 |
| K143693 | MEDLINE SHARPS CONTAINERS | Medline Industries, Inc. | 2015-11-06 | 317 | 0 |
| K151249 | PUREWAY SHARPS COLLECTOR 1.2 GALLON, PUREWAY SHARPS COLLECTO | Pureway Compliance, Inc. | 2015-09-04 | 115 | 0 |
| K150333 | MedSource Sharps Dart | Medsource International, LLC | 2015-05-08 | 87 | 0 |
| K140285 | B TRAVELSAVVY SHARPS CONTAINER | Bellegrove Medical Supply, Inc. | 2014-12-04 | 303 | 0 |
| K141759 | OAK RIDGE PRODUCTS MULTI-PURPOSE SHARPS CONTAINERS | Oak Ridge Products, LLC | 2014-10-24 | 115 | 0 |
| K132476 | SHARPS CONTAINER | Grp & Associates | 2014-05-02 | 267 | 0 |
| K131708 | BWCSH-1 SHARPS CONTAINER | Bradford Wright Companies, Inc. | 2014-03-10 | 272 | 0 |
| K132767 | MEDLINE SHARPS CONTAINER | Medline Industries, Inc. | 2014-02-03 | 152 | 0 |
| K132792 | ECOSHIP DISPOSABLE SHARPS CONTAINER, ECOSHIP DISPOSABLE SHAR | Daniels Sharpsmart, Inc. | 2014-01-31 | 147 | 0 |
| K132007 | STERICYCLE SHARPS MANAGEMENT SERVICE REUSABLE SHARPS CONTAIN | Stericycle, Inc. | 2013-12-27 | 179 | 0 |
| K133031 | SHARPSOLOGY 2 | Industrial Water Solutions, Inc. | 2013-11-15 | 50 | 0 |
| K123807 | SHARPSCAN | Medical Engineering Development Solutions, Inc. | 2013-07-23 | 224 | 0 |
| K131087 | SHARPSTANK REUSABLE SHARPS CONTAINER | Rehrig Pacific Company | 2013-07-12 | 85 | 0 |
| K130281 | OAK RIDGE PRODUCTS SHARP CONTAINER | Oak Ridge Products, LLC | 2013-06-21 | 136 | 0 |
| K111085 | SHARPS TANK REUSABLE SHARPS CONTAINER | Rehrig Pacific Company | 2012-04-25 | 372 | 0 |
| K112774 | BD RECYKLEEN SHARPS COLLECTORS | Becton, Dickinson and Company | 2012-03-28 | 187 | 0 |
| K110262 | SHARPS CONTAINER | Noble Marketing | 2011-04-05 | 67 | 0 |
| K101567 | SHARPS CONTAINER | Cixi Leinuo Plastic Co., Ltd. | 2010-09-02 | 90 | 0 |
| K091736 | SHARPSMART DISPOSABLE SHARPS CONTAINER, MODEL S2 | Daniels Corporation Pty, Inc. | 2009-10-30 | 141 | 0 |
| K091690 | SHARP CHUTE | Heathrow Scientific, LLC | 2009-07-28 | 48 | 0 |
| K090157 | ISOLYSER HOME SHARPS MANAGEMENT (HSM), MODEL 800M; ISOLY SHA | Wcm Waste & Compliance Management, Inc. | 2009-05-04 | 102 | 0 |
| K083511 | ENVIRO SHARP SOLUTIONS 3 | Industrial Water Solutions, Inc. | 2009-03-03 | 97 | 0 |
| K083129 | SHARPS COMPLIANCE CONTAINER | Sharps Compliance, Inc. | 2008-12-15 | 54 | 0 |
| K082042 | GONGDONG DISPOSABLE SHARP CONTAINER | Zhejiang Gongdong Medical Plastic Factory | 2008-09-03 | 47 | 0 |
| K081821 | D.A.R.T. PRO KIT (D.A.R.T. PRO HANDLE AND X-TRACTOR TIP) | Global Pathogen Solutions, Inc. | 2008-09-02 | 67 | 0 |
| K073577 | SHARPS TRANSPORT TUBE, MODEL 50035 | Sharps Compliance, Inc. | 2008-06-23 | 186 | 0 |
| K081449 | ULTIGUARD HOME INSULIN PEN NEEDLE DISPENSER AND SHARPS CONTA | Ultimed, Inc. | 2008-06-03 | 11 | 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