510(k) · Cleared
ClearedOak Ridge Products Multi-Purpose 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 Oct 24, 2014 as substantially equivalent to K130281 (Oak Ridge Products, LLC, 2013) after a 115-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Oct 24, 2014
- Review
- 115 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. No later device cites it as a predicate yet.
- 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 deviceK141759 Oak Ridge Products Multi-Purpose Sharps ContainersOak Ridge Products, LLC · 2014
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) | K141759 | Oak Ridge Products Multi-Purpose Sharps Containers | Oak Ridge Products, LLC | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 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…keted Equivalent Device: Company Product 510(k)# Oak Ridge Products 1 quart Phlebotomy K130281 Sharps Container Oak Ridge Products 2 Gallon Sharps Container K130… | 2013 |
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 20 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.
- 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. 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?
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.
The containers 0330-150S and 0370-1500 are intended to be used in areas where there is no unsupervised patient access.
The 0330-150M container with the counterbalanced closure is intended to be used in areas that have unsupervised patient access.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141759 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141759: Oak Ridge Products Multi-Purpose 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/K141759
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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