510(k) · Cleared
ClearedStericycle Sharps Management Service Reusable Sharps Container, 2 Gallon, Red, Stericycle Sharps Management Services Reu
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stericycle, Inc. · MMK Container, Sharps
Cleared on Dec 27, 2013 as substantially equivalent to K001337 (The Daniels Corp., 2000) after a 179-day review. Its family tree reaches back 1 generation to 2000. 2 later devices descend from it.
- Decided
- Dec 27, 2013
- Review
- 179 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K001337 (2000). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK001337 Daniels Sharpsmart Reusable Sharps ContainerThe Daniels Corp. · 2000
- This deviceK132007 Stericycle Sharps Management Service Reusable Sharps Container, 2…Stericycle, Inc. · 2013
- Descendant · cites it directly · 1 of its ownK153363 Red2Green Reusable Sharps ContainerTriumvirate Environmental, Inc. · 2016
- Descendant · 2 generations on · 0 of its ownK203305 Tiger Reusable Sharps ContainerInternational Marketing Specialists, Inc. · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K001337 | Daniels Sharpsmart Reusable Sharps Container | The Daniels Corp. | 2000 | — |
| 0 (this device) | K132007 | Stericycle Sharps Management Service Reusable Sharps Container, 2 Gallon, Red… | Stericycle, Inc. | 2013 | — |
| +1 | K153363 | Red2Green Reusable Sharps Container | Triumvirate Environmental, Inc. | 2016 | — |
| +2 | K203305 | Tiger Reusable Sharps Container | International Marketing Specialists, Inc. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K001337 | Daniels Sharpsmart Reusable Sharps ContainerSummary page 2…510(k) PREMARKET NOTIFICATION 510(k) SUMMARY PREDICATE DEVICE *Daniels Sharpsmart m reusable shamps container (K00 1337) INTENDED USE The Stericycle Sharps Management Service Reusable Sharps Container is intended for use in health care facilities f… | 2000 |
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 |
|---|---|---|---|
| K153363 | Red2Green Reusable Sharps Container | 2016 | 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?
- Its one ancestor has no recall.
- Of its descendants, K153363 (Triumvirate Environmental, Inc., 2016) 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. 2013, 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?
The Stericycle Sharps Management Service Reusable Sharps Container is intended for use in health care facilities for the storage and transport for disposal of syringes and other medical sharps waste.
The Stericycle Sharps Management Service Reusable Sharps Container is available in the following configurations:
* 2 gallon: 6.9" x 12.3" x 13.9", Red or Yellow color
* 4 gallon: 6.9" x 12.3" x 21.9", Red or Yellow color
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132007 · printed Nov 3, 2026
Cite this page
510(k) Report. “K132007: Stericycle Sharps Management Service Reusable Sharps Container, 2 Gallon, Red, Stericycle Sharps Management Services Reu.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K132007
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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