510(k) · Cleared
ClearedMedline Sharps Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medline Industries, Inc. · MMK Container, Sharps
Cleared on Feb 3, 2014 after a 152-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 8 later devices descend from it.
- Decided
- Feb 3, 2014
- Review
- 152 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 0
8 later devices descend from it, 2 citing it directly.
- This deviceK132767 Medline Sharps ContainerMedline Industries, Inc. · 2014
- Descendant · cites it directly · 6 of its ownK143693 Medline Sharps ContainersMedline Industries, Inc. · 2015
- Descendant · 2 generations on · 5 of its ownK190240 Tiger Sharps ContainersInternational Marketing Specialists, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK211464 Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd. · 2021
- Descendant · 3 generations on · 1 of its ownK222905 Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon…Ningbo Maxcon Medical Technology Co., Ltd. · 2023
- Descendant · 4 generations on · 0 of its ownK253222 Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K143693Medline Sharps ContainersMedline Industries, Inc. · 2015 · cites it directly6descendants
- K190240Tiger Sharps ContainersInternational Marketing Specialists, Inc. · 2019 · 2 generations on5descendants
- K211464Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd. · 2021 · 3 generations on2descendants
- K222905Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT…Ningbo Maxcon Medical Technology Co., Ltd. · 2023 · 3 generations on1descendant
- K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K132767 | Medline Sharps Container | Medline Industries, Inc. | 2014 | — |
| +1 | K143693 | Medline Sharps Containers | Medline Industries, Inc. | 2015 | — |
| +2 | K190240 | Tiger Sharps Containers | International Marketing Specialists, Inc. | 2019 | — |
| +3 | K211464 | Nitta M&T Safety Box | Nitta M&T (Thailand) Co., Ltd. | 2021 | — |
| +3 | K222905 | Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps… | Ningbo Maxcon Medical Technology Co., Ltd. | 2023 | — |
| +4 | K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Zhejiang Gongdong Medical Technology Co., Ltd. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MMK? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MMK device
- #1 K253773 Guanhong Sharps Container (GHW-1F1); Guanhong…score 12.3 · 4 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (8)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K143693 (Medline Industries, Inc., 2015) has gone furthest, with 6 descendants of its own.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · MMK
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MMK
84in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MMK
No recall names MMK since 2007.
Adverse event reports per year · MMK
5in 2025
MAUDE reports naming product code MMK, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 4 | 63 | 0 | 5 |
| 2008 | 6 | 61 | 0 | 21 |
| 2009 | 4 | 100 | 0 | 9 |
| 2010 | 1 | — | 0 | 9 |
| 2011 | 1 | — | 0 | 16 |
| 2012 | 2 | — | 0 | 16 |
| 2013 | 5 | 136 | 0 | 20 |
| 2014 | 6 | 210 | 0 | 13 |
| 2015 | 3 | 115 | 0 | 13 |
| 2016 | 4 | 258 | 0 | 27 |
| 2017 | 1 | — | 0 | 39 |
| 2018 | 1 | — | 0 | 63 |
| 2019 | 4 | 265 | 0 | 56 |
| 2020 | 1 | — | 0 | 62 |
| 2021 | 3 | 149 | 0 | 85 |
| 2022 | 1 | — | 0 | 38 |
| 2023 | 3 | 251 | 0 | 34 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 3 | 84 | 0 | 5 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
Medline Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K132767 · printed Nov 5, 2026
Cite this page
510(k) Report. “K132767: Medline Sharps Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K132767
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026