510(k) · Cleared
ClearedBD Recykleen Sharps Collectors
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · MMK Container, Sharps
Cleared on Mar 28, 2012 as substantially equivalent to K943134 (Med-Safe Systems, Inc., 1994) after a 187-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Mar 28, 2012
- Review
- 187 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943134 (1994). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK943134 B-D Guardian Nestable Sharps CollectorsMed-Safe Systems, Inc. · 1994
- This deviceK112774 BD Recykleen Sharps CollectorsBecton, Dickinson and Company · 2012
- Descendant · cites it directly · 2 of its ownK132476 Sharps ContainerGrp & Associates · 2014
- Descendant · 2 generations on · 1 of its ownK151249 Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2…Pureway Compliance, Inc. · 2015
- Descendant · 3 generations on · 0 of its ownK251874 PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc. · 2025
Most influential descendants
Showing 3 of 3 · See all- K132476Sharps ContainerGrp & Associates · 2014 · cites it directly2descendants
- K151249Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon, Pureway Sharps…Pureway Compliance, Inc. · 2015 · 2 generations on1descendant
- K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc. · 2025 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943134 | B-D Guardian Nestable Sharps Collectors | Med-Safe Systems, Inc. | 1994 | — |
| 0 (this device) | K112774 | BD Recykleen Sharps Collectors | Becton, Dickinson and Company | 2012 | — |
| +1 | K132476 | Sharps Container | Grp & Associates | 2014 | — |
| +2 | K151249 | Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon… | Pureway Compliance, Inc. | 2015 | — |
| +3 | K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) | Pureway Compliance, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2025 | 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 |
|---|---|---|---|
| * | K943134 | B-D Guardian Nestable Sharps CollectorsSummary page 2…d in current. BD Sharps Collectors and RD RecykleenTM Sharps Collectors. The predicated devices were previously cleared under K943 134. The basis of this new Traditional 5 10(k) submission is for a material change of… | 1994 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K132476 | Sharps Container | 2014 | 2 |
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?
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2012, 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?
Sharps collectors are intended to be used for the disposal of contaminated medical sharps in health care facilities.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K112774 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112774: BD Recykleen Sharps Collectors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112774
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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