510(k) · Cleared
ClearedSterisharp 3-Gallon RSDC, Model RSDC3G
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sterilogic Waste Systems, Inc. · MMK Container, Sharps
Cleared on May 14, 2002 as substantially equivalent to K931664 (Bemis Mfg. Co., 1994) and 1 other predicate after a 74-day review. Its family tree reaches back 2 generations to 1997. 3 later devices descend from it.
- Decided
- May 14, 2002
- Review
- 74 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K964387 (1997). 3 ancestors in all, the oldest K931664 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK964387 Point of Use II Sharps-a-GatorGraphic Controls Corp. · 1997
- 1 generation backK991612 Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5GSterilogic Waste Systems, Inc. · 1999
- This deviceK020664 Sterisharp 3-Gallon RSDC, Model RSDC3GSterilogic Waste Systems, Inc. · 2002
- Descendant · cites it directly · 1 of its ownK083511 Enviro Sharp Solutions 3Industrial Water Solutions, Inc. · 2009
- Descendant · 2 generations on · 0 of its ownK131087 Sharpstank Reusable Sharps ContainerRehrig Pacific Company · 2013
- Descendant · cites it directly · 0 of its ownK081821 D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip)Global Pathogen Solutions, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See all- K083511Enviro Sharp Solutions 3Industrial Water Solutions, Inc. · 2009 · cites it directly1descendant
- K131087Sharpstank Reusable Sharps ContainerRehrig Pacific Company · 2013 · 2 generations on0descendants
- K081821D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip)Global Pathogen Solutions, Inc. · 2008 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964387 | Point of Use II Sharps-a-Gator | Graphic Controls Corp. | 1997 | — |
| −1 | K991612 | Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5G | Sterilogic Waste Systems, Inc. | 1999 | — |
| 0 (this device) | K020664 | Sterisharp 3-Gallon RSDC, Model RSDC3G | Sterilogic Waste Systems, Inc. | 2002 | — |
| +1 | K083511 | Enviro Sharp Solutions 3 | Industrial Water Solutions, Inc. | 2009 | — |
| +2 | K131087 | Sharpstank Reusable Sharps Container | Rehrig Pacific Company | 2013 | — |
| +1 | K081821 | D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip) | Global Pathogen Solutions, Inc. | 2008 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K931664 | Sharps Disposable ContainersSummary page 1…COMMON NAME: REUSABLE SHARPS DISPOSAL CONTAINER CLASSIFICATION: CLASS II - ACCESSORY DEVICE 807.92(a)(3) EQUIVALENT DEVICE #1: BEMIS SHARPS DISPOSAL CONTAINER (510[k] #K931664) ' CONTAINER LID: The Bemis Sharps Disposal Container lid (‘lid”) is used on the top of the StenSharpTM 3 container. This Bemis… | 1994 |
| * | K991612 | Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5G Our OCR of the scanned summary read K991662, FDA’s number for Titanium Hartshill System (Surgicraft, Ltd.). Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “SteriSharp 2.5-Gallon RSDC”. | 1999 |
What descends from it? (3)
2 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?
- The line of descent spans 5 years and passes through 2 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K083511 (Industrial Water Solutions, Inc., 2009) has gone furthest, with 1 descendant 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 SteriSharp™ 3-Gallon RSDC reusable containers are intended for use by healthcare providers (hospitals, laboratories, medical clinics, veterinary clinics, and other such areas and facilities where needles, sharps waste and other infectious waste is generated). The containers are designed to safely contain sharps waste prior to removal from generating facility and until ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse.
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/K020664 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020664: Sterisharp 3-Gallon RSDC, Model RSDC3G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020664
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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