510(k) · Cleared
ClearedSharpstank Reusable Sharps Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Rehrig Pacific Company · MMK Container, Sharps
Cleared on Jul 12, 2013 as substantially equivalent to K083511 (Industrial Water Solutions, Inc., 2009) after an 85-day review. Its family tree reaches back 4 generations to 1997.
- Decided
- Jul 12, 2013
- Review
- 85 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K964387 (1997). 6 ancestors in all, the oldest K931664 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK964387 Point of Use II Sharps-a-GatorGraphic Controls Corp. · 1997
- 3 generations backK991612 Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5GSterilogic Waste Systems, Inc. · 1999
- 2 generations backK020664 Sterisharp 3-Gallon RSDC, Model RSDC3GSterilogic Waste Systems, Inc. · 2002
- 1 generation backK083511 Enviro Sharp Solutions 3Industrial Water Solutions, Inc. · 2009
- This deviceK131087 Sharpstank Reusable Sharps ContainerRehrig Pacific Company · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K964387 | Point of Use II Sharps-a-Gator | Graphic Controls Corp. | 1997 | — |
| −3 | K991612 | Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5G | Sterilogic Waste Systems, Inc. | 1999 | — |
| −2 | K020664 | Sterisharp 3-Gallon RSDC, Model RSDC3G | Sterilogic Waste Systems, Inc. | 2002 | — |
| −1 | K083511 | Enviro Sharp Solutions 3 | Industrial Water Solutions, Inc. | 2009 | — |
| 0 (this device) | K131087 | Sharpstank Reusable Sharps Container | Rehrig Pacific Company | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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 |
|---|---|---|---|
| * | K083511 | Enviro Sharp Solutions 3Summary page 1…Class 11 Product Code: 80 MMK 21 CFR 880.5570 Predicate Device: K083511I Industrial Water Solutions, Inc. (Sharpsology) Env… | 2009 |
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 16 years and passes through 4 companies; a new generation was cleared every 4.4 years on median.
- 1 of the 6 ancestors has a recall of any class.
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?
Rehrig Healthcare's reusable 4.9 gallon sharps containers are intended to be used for the collection and transportation of used medical sharps. The containers are intended to be used by healthcare workers in hospitals, clinics, physician offices, dental offices laboratories, veterinarian offices, and other area where sharps disposal is needed.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131087 · printed Nov 5, 2026
Cite this page
510(k) Report. “K131087: Sharpstank 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/K131087
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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