510(k) · Cleared
ClearedSharpsmart Disposable Sharps Container, Model S2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Daniels Corporation Pty, Inc. · MMK Container, Sharps
Cleared on Oct 30, 2009 as substantially equivalent to K072667 (Solutions, Inc., 2007) after a 141-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Oct 30, 2009
- Review
- 141 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K943575 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK943575 B-D Guardian Nestable Sharps CollectorsBd Becton Dickinson Vacutainer Systems Preanalytic · 1994
- 1 generation backK072667 Sharps Away Disposable ContainerSolutions, Inc. · 2007
- This deviceK091736 Sharpsmart Disposable Sharps Container, Model S2Daniels Corporation Pty, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK132792 Ecoship Disposable Sharps Container, Ecoship Disposable Sharps…Daniels Sharpsmart, Inc. · 2014
Most influential descendants
Showing 1 of 1 · See all- K132792Ecoship Disposable Sharps Container, Ecoship Disposable Sharps ContainerDaniels Sharpsmart, Inc. · 2014 · cites it directly0descendants
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) | K091736 | Sharpsmart Disposable Sharps Container, Model S2 | Daniels Corporation Pty, Inc. | 2009 | — |
| +1 | K132792 | Ecoship Disposable Sharps Container, Ecoship Disposable Sharps Container | Daniels Sharpsmart, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 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 |
|---|---|---|---|
| * | K072667 | Sharps Away Disposable ContainerSummary page 1…: Company Product 510(k)# Solutions, Inc Sharps Away Disposable Container K072667 510(k) Daniels Sharpsmart P a ge 4 DESCRIPTION OF DEVIC… | 2007 |
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 |
|---|---|---|---|
| K132792 | Ecoship Disposable Sharps Container, Ecoship Disposable Sharps Container | 2014 | 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 15 years and passes through 3 companies; a new generation was cleared every 13.0 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K132792 (Daniels Sharpsmart, Inc., 2014) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K072667.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
Sharpsmart S2 disposable sharps container 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 office and other small quantity waste generators for the safe disposal of hazardous sharps. This device is intended for "Over-the-Counter" use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091736 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091736: Sharpsmart Disposable Sharps Container, Model S2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091736
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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