510(k) · Cleared
ClearedBemis Two Gallon Chemotherapy Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bemis Mfg. Co. · MMK Container, Sharps
Cleared on Feb 11, 1997 after a 69-day review. The FDA summary names its predicate without a number. 1 later device descends from it.
- Decided
- Feb 11, 1997
- Review
- 69 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK964858 Bemis Two Gallon Chemotherapy ContainerBemis Mfg. Co. · 1997
- Descendant · cites it directly · 0 of its ownK180983 Maxcon Two Gallon Chemotherapy ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019
Most influential descendants
Showing 1 of 1 · See all- K180983Maxcon Two Gallon Chemotherapy ContainerNingbo Maxcon Medical Technology Co., Ltd. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K964858 | Bemis Two Gallon Chemotherapy Container | Bemis Mfg. Co. | 1997 | — |
| +1 | K180983 | Maxcon Two Gallon Chemotherapy Container | Ningbo Maxcon Medical Technology Co., Ltd. | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 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 |
|---|---|---|---|
| * | — | Baxter Two Gallon Chemotherapy Container Named without a submission number |
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 |
|---|---|---|---|
| K180983 | Maxcon Two Gallon Chemotherapy Container | 2019 | 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?
- Of its descendants, K180983 (Ningbo Maxcon Medical Technology Co., Ltd., 2019) has gone furthest, with 0 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 | — |
What is it indicated for?
The Bernis Twn Gallon Chemotherapy Container is a sharps disposal container. Itis intended for the safe disposal of needles, syringes, and other chemotherapy waste in arcas with controlled access which typically include nurse’s stations, oncology, pharmacies, and chemotherapy treatment rooms.
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/K964858 · printed Nov 4, 2026
Cite this page
510(k) Report. “K964858: Bemis Two Gallon Chemotherapy Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K964858
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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