510(k) · Cleared
ClearedOak Ridge Products Sharps Containers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Oak Ridge Products, LLC · MMK Container, Sharps
Cleared on Jun 9, 2016 as substantially equivalent to K130281 (Oak Ridge Products, LLC, 2013) after a 43-day review. Its family tree reaches back 2 generations to 1994. 3 later devices descend from it.
- Decided
- Jun 9, 2016
- Review
- 43 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K943575 (1994). 4 ancestors in all. 3 later devices descend from it, 1 citing it directly.
- Root · 2 generations backK943575 B-D Guardian Nestable Sharps CollectorsBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- 1 generation backK130281 Oak Ridge Products Sharp ContainerOak Ridge Products, LLC · 2013
- This deviceK161180 Oak Ridge Products Sharps ContainersOak Ridge Products, LLC · 2016
- Descendant · cites it directly · 2 of its ownK180984 Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 0 of its ownK253773 Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container…Taizhou Huangyan Guanhong Plastic Steel Products Factory · 2026
- 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 3 of 3 · See all- K180984Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019 · cites it directly2descendants
- K253773Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4); Guanhong…Taizhou Huangyan Guanhong Plastic Steel Products Factory · 2026 · 2 generations on0descendants
- 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 |
|---|---|---|---|---|---|
| −2 | K943575 | B-D Guardian Nestable Sharps Collectors | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1994 | — |
| −1 | K130281 | Oak Ridge Products Sharp Container | Oak Ridge Products, LLC | 2013 | — |
| 0 (this device) | K161180 | Oak Ridge Products Sharps Containers | Oak Ridge Products, LLC | 2016 | — |
| +1 | K180984 | Maxcon Sharps Container | Ningbo Maxcon Medical Technology Co., Ltd. | 2019 | — |
| +2 | K253773 | Guanhong Sharps Container (GHW-1F1); Guanhong Sharps Container (GHW-1F4)… | Taizhou Huangyan Guanhong Plastic Steel Products Factory | 2026 | — |
| +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 |
|---|---|---|
| 1995 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K130281 | Oak Ridge Products Sharp ContainerSummary page 4…evice: Company Product 510(k)# Oak Ridge Products 1 quart Phlebotomy Sharps Container K130281 Oak Ridge Products 2 Gallon Sharps Container K130281 Oak Ridge Products Sharps Containers… | 2013 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180984 | Maxcon Sharps Container | 2019 | 2 |
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 22 years and passes through 2 companies; a new generation was cleared every 18.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K180984 (Ningbo Maxcon Medical Technology Co., Ltd., 2019) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K130281.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, 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?
Oak Ridge Products Sharps containers are a single-use, disposable, non-sterile containers intended to be used for healthcare purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for trained healthcare professionals.
All the containers are intended to be used in areas where there is no unsupervised patient access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161180 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161180: Oak Ridge Products 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/K161180
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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