510(k) · Cleared
ClearedSharpsology 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Industrial Water Solutions, Inc. · MMK Container, Sharps
Cleared on Nov 15, 2013 as substantially equivalent to K992626 (Sure-Way Systems, Inc., 1999) and 1 other predicate after a 50-day review. Its family tree reaches back 2 generations to 1994.
- Decided
- Nov 15, 2013
- Review
- 50 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K943575 (1994). 3 ancestors in all. No later device cites it as a predicate yet.
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 | K072667 | Sharps Away Disposable Container | Solutions, Inc. | 2007 | — |
| 0 (this device) | K133031 | Sharpsology 2 | Industrial Water Solutions, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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? (2)
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 |
|---|---|---|---|
| * | K992626 | Sure-Way Reusable Sharps ContainerSummary page 1…. Container and is a Mailbox Style lid., The Sure-Way Sharps Container lid has been approved under 5l10(k) 4K992626. EQUIVALENT DEVICE 42: Sharps Awvay Vertical Drop Lid CONTAINER LID..CANTEEN STYLE The Sharps Away Vertical drop lid… | 1999 |
| * | K072667 | Sharps Away Disposable ContainerSummary page 1…Sharps Container and is a canteen style lid. The Sharps Away Vertical Drop Lid has been approved under 5 10(k) #072667 EQUIVALENT DEVICE #3 Sure-Way Reusable Sharps Container IS I0(k) #K992626 CONTAINER BASE: The… | 2007 |
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 19 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
- None of the 3 ancestors has a recall.
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 container is intended for use in healthcare settings. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps. The container features a canteen style, vertical drop lid or a mailbox style, vertical drop lid. The container is housed in a wall mount attached to the wall. The container is translucent and can be selected in a natural or…
Read the full statement (213 words)
The container is intended for use in healthcare settings. The container is designed to safely contain sharps prior to removal from the generating facility, during transportation and until ultimate treatment and disposal of the sharps.
The container features a canteen style, vertical drop lid or a mailbox style, vertical drop lid. The container is housed in a wall mount attached to the wall. The container is translucent and can be selected in a natural or red color, The lid is a natural color. The wall mount is a natural color with a clear door. The container volume is 2.25 gallons up to the fill line.
The dimensions of the container are 13.173 inches wide, 11.417 inches high and 5.993 inches in depth (front to back). The lid surface dimensions for the canteen style lid are 6.197 inches wide and 13.031 inches long. The dimensions for the mailbox style lid are 6.194 inches wide and 13.029 inches long. The diameter of the lid aperture for the canteen style, vertical drop lid is 2.135 inches. The opening of the lid aperture for the mailbox style, vertical drop lid is 2.5 inches by 9.5 inches.
The dimensions of the wall mount are 12.25 inches wide, 16.625 inches high and 6.75 inches in depth (front to back).
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K133031 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133031: Sharpsology 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133031
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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