510(k) · Cleared
ClearedGongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Zhejiang Gongdong Medical Technology Co., Ltd. · MMK Container, Sharps
Cleared on Dec 22, 2025 as substantially equivalent to K222905 (Ningbo Maxcon Medical Technology Co., Ltd., 2023) and 1 other predicate after an 84-day review. Its family tree reaches back 5 generations to 2014.
- Decided
- Dec 22, 2025
- Review
- 84 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K132767 (2014). 13 ancestors in all, the oldest K943575 (1994). No later device cites it as a predicate yet.
- Root · 5 generations backK132767 Medline Sharps ContainerMedline Industries, Inc. · 2014
- 4 generations backK143693 Medline Sharps ContainersMedline Industries, Inc. · 2015
- 3 generations backK190240 Tiger Sharps ContainersInternational Marketing Specialists, Inc. · 2019
- 2 generations backK211464 Nitta M&T Safety BoxNitta M&T (Thailand) Co., Ltd. · 2021
- 1 generation backK222905 Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon…Ningbo Maxcon Medical Technology Co., Ltd. · 2023
- This deviceK253222 Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G)Zhejiang Gongdong Medical Technology Co., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K132767 | Medline Sharps Container | Medline Industries, Inc. | 2014 | — |
| −4 | K143693 | Medline Sharps Containers | Medline Industries, Inc. | 2015 | — |
| −3 | K190240 | Tiger Sharps Containers | International Marketing Specialists, Inc. | 2019 | — |
| −2 | 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 | — |
| 0 (this device) | 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 |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2013 | 1 | 0 |
| 2016 | 2 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K222905 | Maxcon Sharps Container (1 QT Sharps Container, MA1112), Maxcon Sharps Container (5.4 QT…Summary page 6…Manufacturer Device Name Trade Name 510(k) Number Ningbo Maxcon Medical Sharps Container Maxcon Sharps K222905 Technology Co., Ltd Container (MA1112) Ningbo Maxcon Medical Sharps Container Maxcon… | 2023 |
| * | K180984 | Maxcon Sharps ContainerSummary page 6…K222905 Technology Co., Ltd Container (MA1112) Ningbo Maxcon Medical Sharps Container Maxcon Sharps K180984 Technology Co., Ltd Container (MA1221) D. Indications for Use: Gongdong sharps Containers (SCR-… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 11 years and passes through 5 companies; a new generation was cleared every 2.3 years on median.
- None of the 13 ancestors has a recall.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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?
Gongdong sharps Containers (SCR-01Q, SCR-01G, SCR-03G) 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 needles, syringes, lancets and etc. 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 in contact with or available to the patient in normal use, and all device models are not for use in areas with unsupervised patient access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253222 · printed Nov 6, 2026
Cite this page
510(k) Report. “K253222: Gongdong Sharps Container (SCR-01Q, SCR-01G, SCR-03G).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K253222
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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