510(k) · Cleared
ClearedNitta M&T Safety Box
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nitta M&T (Thailand) Co., Ltd. · MMK Container, Sharps
Cleared on Sep 14, 2021 as substantially equivalent to K152340 (North American Rescue, LLC, 2016) and 1 other predicate after a 126-day review. Its family tree reaches back 3 generations to 2014. 2 later devices descend from it.
- Decided
- Sep 14, 2021
- Review
- 126 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K132767 (2014). 5 ancestors in all, the oldest K972279 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK132767 Medline Sharps ContainerMedline Industries, Inc. · 2014
- 2 generations backK143693 Medline Sharps ContainersMedline Industries, Inc. · 2015
- 1 generation backK190240 Tiger Sharps ContainersInternational Marketing Specialists, Inc. · 2019
- This deviceK211464 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
Most influential descendants
Showing 2 of 2 · See all- 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
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K132767 | Medline Sharps Container | Medline Industries, Inc. | 2014 | — |
| −2 | K143693 | Medline Sharps Containers | Medline Industries, Inc. | 2015 | — |
| −1 | K190240 | Tiger Sharps Containers | International Marketing Specialists, Inc. | 2019 | — |
| 0 (this device) | 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 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K152340 | NAR Sharps Shuttle; NAR Sharps Shuttle Pack of sixSummary page 10…Predicate Device Comparison 510(k) NA K152340 K190240 n/a Device Name Nitta M&T Safety Box North American… | 2016 |
| * | K190240 | Tiger Sharps ContainersSummary page 10…Predicate Device Comparison 510(k) NA K152340 K190240 n/a Device Name Nitta M&T Safety Box North American Tiger Sharps Conta… | 2019 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K222905 | Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT… | 2023 | 1 |
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 7 years and passes through 3 companies; a new generation was cleared every 2.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K222905 (Ningbo Maxcon Medical Technology Co., Ltd., 2023) has gone furthest, with 1 descendant 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. 2021, 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?
Nitta M&T Safety Boxes are intended to provide a receptacle for used, contaminated medical sharps and act as an enclosure during transport to ultimate disposal. The device is intended to be used for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles by qualified personnel in health care facilities and other facilities in which medical sharps may be used. The device is not in contact with or available to the patient in normal use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K211464 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211464: Nitta M&T Safety Box.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K211464
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