510(k) · Cleared
ClearedRed2Green Reusable Sharps Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Triumvirate Environmental, Inc. · MMK Container, Sharps
Cleared on Jul 26, 2016 as substantially equivalent to K132007 (Stericycle, Inc., 2013) and 2 other predicates after a 249-day review. Its family tree reaches back 2 generations to 2000. 1 later device descends from it.
- Decided
- Jul 26, 2016
- Review
- 249 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K001337 (2000). 4 ancestors in all, the oldest K950897 (1995). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK001337 Daniels Sharpsmart Reusable Sharps ContainerThe Daniels Corp. · 2000
- 1 generation backK132007 Stericycle Sharps Management Service Reusable Sharps Container, 2…Stericycle, Inc. · 2013
- This deviceK153363 Red2Green Reusable Sharps ContainerTriumvirate Environmental, Inc. · 2016
- Descendant · cites it directly · 0 of its ownK203305 Tiger Reusable Sharps ContainerInternational Marketing Specialists, Inc. · 2021
Most influential descendants
Showing 1 of 1 · See all- K203305Tiger Reusable Sharps ContainerInternational Marketing Specialists, Inc. · 2021 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K001337 | Daniels Sharpsmart Reusable Sharps Container | The Daniels Corp. | 2000 | — |
| −1 | K132007 | Stericycle Sharps Management Service Reusable Sharps Container, 2 Gallon, Red… | Stericycle, Inc. | 2013 | — |
| 0 (this device) | K153363 | Red2Green Reusable Sharps Container | Triumvirate Environmental, Inc. | 2016 | — |
| +1 | K203305 | Tiger Reusable Sharps Container | International Marketing Specialists, Inc. | 2021 | — |
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 |
|---|---|---|
| 2021 | 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? (3)
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 |
|---|---|---|---|
| * | K132007 | Stericycle Sharps Management Service Reusable Sharps Container, 2 Gallon, Red…Summary page 6…icate Device Name / Manufacturer Primary Number Predicate K132007 Stericycle Sharps Management Service Reusable Sharps Container /… | 2013 |
| * | K950897 | Biobox Traptop (Small, Medium, Large and X-Large)Summary page 6…ps Management Service Reusable Sharps Container / Stericycle, Inc. K950897 Biobox TrapTop / Biosystems K950898 Biobox with Funnel Top / Biosystems SUMMARY OF NON‐CLINICAL TESTING No FDA performance sta… | 1995 |
| * | K950898 | Biobox with Funnel Top (Small, Medium, Large, and X-Large)Summary page 6…Container / Stericycle, Inc. K950897 Biobox TrapTop / Biosystems K950898 Biobox with Funnel Top / Biosystems SUMMARY OF NON‐CLINICAL TESTING No FDA performance standards have been established for the R… | 1995 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203305 | Tiger Reusable Sharps Container | 2021 | 0 |
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 16 years and passes through 3 companies; a new generation was cleared every 13.5 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K203305 (International Marketing Specialists, Inc., 2021) has gone furthest, with 0 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. 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?
Red2Green Reusable Sharps Containers and accessories are intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal, storage and transportation of hazardous sharps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153363 · printed Nov 5, 2026
Cite this page
510(k) Report. “K153363: Red2Green Reusable Sharps Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K153363
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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