510(k) · Cleared
ClearedTiger Sharps Containers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Marketing Specialists, Inc. · MMK Container, Sharps
Cleared on May 31, 2019 as substantially equivalent to K143693 (Medline Industries, Inc., 2015) after a 114-day review. Its family tree reaches back 2 generations to 2014. 5 later devices descend from it.
- Decided
- May 31, 2019
- Review
- 114 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K132767 (2014). 5 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK132767 Medline Sharps ContainerMedline Industries, Inc. · 2014
- 1 generation backK143693 Medline Sharps ContainersMedline Industries, Inc. · 2015
- This deviceK190240 Tiger Sharps ContainersInternational Marketing Specialists, Inc. · 2019
- Descendant · cites it directly · 2 of its ownK211464 Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd. · 2021
- Descendant · cites it directly · 1 of its ownK222905 Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon…Ningbo Maxcon Medical Technology Co., Ltd. · 2023
- Descendant · 2 generations on · 0 of its ownK253222 Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025
- Descendant · cites it directly · 0 of its ownK211890 Promisemed Sharps containerPromisemed Hangzhou Meditech Co., Ltd. · 2021
- Descendant · cites it directly · 0 of its ownK201523 Sharps containerZhejiang Gongdong Medical Technology Co., Ltd. · 2020
Most influential descendants
Showing 5 of 5 · See all- K211464Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd. · 2021 · cites it directly2descendants
- K222905Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT…Ningbo Maxcon Medical Technology Co., Ltd. · 2023 · cites it directly1descendant
- K253222Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025 · 2 generations on0descendants
- K211890Promisemed Sharps containerPromisemed Hangzhou Meditech Co., Ltd. · 2021 · cites it directly0descendants
- K201523Sharps containerZhejiang Gongdong Medical Technology Co., Ltd. · 2020 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K132767 | Medline Sharps Container | Medline Industries, Inc. | 2014 | — |
| −1 | K143693 | Medline Sharps Containers | Medline Industries, Inc. | 2015 | — |
| 0 (this device) | K190240 | Tiger Sharps Containers | International Marketing Specialists, Inc. | 2019 | — |
| +1 | K211464 | Nitta M&T Safety Box | Nitta M&T (Thailand) Co., Ltd. | 2021 | — |
| +1 | K222905 | Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps… | Ningbo Maxcon Medical Technology Co., Ltd. | 2023 | — |
| +2 | K253222 | Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G) | Zhejiang Gongdong Medical Technology Co., Ltd. | 2025 | — |
| +1 | K211890 | Promisemed Sharps container | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
| +1 | K201523 | Sharps container | Zhejiang Gongdong Medical Technology Co., Ltd. | 2020 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and 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? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K143693 | Medline Sharps ContainersSummary page 6…MMK III. Predicate Device Information Manufacturer Predicate Device 510(k) Number Submitted Device Medline Sharps Medline Sharps K143693 Tiger Sharps Containers Containers Containers K190240 Page 1 of 6 ==… | 2015 |
What descends from it? (5)
4 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.6 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K211464 (Nitta M&T (Thailand) Co., Ltd., 2021) has gone furthest, with 2 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. 2019, 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?
Tiger Sharps Containers are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal.
The Containers are single-use, disposable, non-sterile containers intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities and other facilities in which medical sharps may be used. All device models are not for use in areas with unsupervised patient access.
All device models only be used with appropriate mounting accessories.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190240 · printed Nov 6, 2026
Cite this page
510(k) Report. “K190240: Tiger Sharps Containers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K190240
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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