510(k) · Cleared
ClearedAncillary and Large Volume Sharps Disposal Containers
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sage Products, Inc. · MMK Container, Sharps
Cleared on Mar 22, 1995 after a 238-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 12 later devices descend from it.
- Decided
- Mar 22, 1995
- Review
- 238 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 0
12 later devices descend from it, 2 citing it directly.
- This deviceK943659 Ancillary and Large Volume Sharps Disposal ContainersSage Products, Inc. · 1995
- Descendant · cites it directly · 7 of its ownK130281 Oak Ridge Products Sharp ContainerOak Ridge Products, LLC · 2013
- Descendant · 2 generations on · 3 of its ownK161180 Oak Ridge Products Sharps ContainersOak Ridge Products, LLC · 2016
- Descendant · cites it directly · 3 of its ownK982781 Demolizer #47 One-Gallon Point of Generation Sharps ContainerThermal Waste Technology, Inc. · 1998
- Descendant · 3 generations on · 2 of its ownK180984 Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019
- Descendant · 2 generations on · 1 of its ownK131708 Bwcsh-1 Sharps ContainerBradford Wright Companies, Inc. · 2014
Showing 5 of 12 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 12 · See all- K130281Oak Ridge Products Sharp ContainerOak Ridge Products, LLC · 2013 · cites it directly7descendants
- K161180Oak Ridge Products Sharps ContainersOak Ridge Products, LLC · 2016 · 2 generations on3descendants
- K982781Demolizer #47 One-Gallon Point of Generation Sharps ContainerThermal Waste Technology, Inc. · 1998 · cites it directly3descendants
- K180984Maxcon Sharps ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019 · 3 generations on2descendants
- K131708Bwcsh-1 Sharps ContainerBradford Wright Companies, Inc. · 2014 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K943659 | Ancillary and Large Volume Sharps Disposal Containers | Sage Products, Inc. | 1995 | — |
| +1 | K130281 | Oak Ridge Products Sharp Container | Oak Ridge Products, LLC | 2013 | — |
| +2 | K161180 | Oak Ridge Products Sharps Containers | Oak Ridge Products, LLC | 2016 | — |
| +1 | K982781 | Demolizer #47 One-Gallon Point of Generation Sharps Container | Thermal Waste Technology, Inc. | 1998 | — |
| +3 | K180984 | Maxcon Sharps Container | Ningbo Maxcon Medical Technology Co., Ltd. | 2019 | — |
| +2 | K131708 | Bwcsh-1 Sharps Container | Bradford Wright Companies, Inc. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 3 | 0 |
| 2016 | 1 | 0 |
| 2019 | 2 | 0 |
| 2023 | 1 | 0 |
| 2025 | 1 | 0 |
| 2026 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (12)
See all 122 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K130281 (Oak Ridge Products, LLC, 2013) has gone furthest, with 7 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.
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 | — |
https://510kreport.com/device/K943659 · printed Nov 6, 2026
Cite this page
510(k) Report. “K943659: Ancillary and Large Volume Sharps Disposal Containers.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K943659
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026