510(k) · Cleared
ClearedSterisharp 2.5-Gallon RSDC, Model #RSDC2.5G
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 28, 1999 as substantially equivalent to K964387 (Graphic Controls Corp., 1997) after an 18-day review. Its family tree reaches back 1 generation to 1997. 4 later devices descend from it.
- Decided
- May 28, 1999
- Review
- 18 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K964387 (1997). 4 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK964387 Point of Use II Sharps-a-GatorGraphic Controls Corp. · 1997
- This deviceK991612 Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5GSterilogic Waste Systems, Inc. · 1999
- Descendant · cites it directly · 3 of its ownK020664 Sterisharp 3-Gallon RSDC, Model RSDC3GSterilogic Waste Systems, Inc. · 2002
- Descendant · 2 generations on · 1 of its ownK083511 Enviro Sharp Solutions 3Industrial Water Solutions, Inc. · 2009
- Descendant · 3 generations on · 0 of its ownK131087 Sharpstank Reusable Sharps ContainerRehrig Pacific Company · 2013
- Descendant · 2 generations on · 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 4 of 4 · See all- K020664Sterisharp 3-Gallon RSDC, Model RSDC3GSterilogic Waste Systems, Inc. · 2002 · cites it directly3descendants
- K083511Enviro Sharp Solutions 3Industrial Water Solutions, Inc. · 2009 · 2 generations on1descendant
- K131087Sharpstank Reusable Sharps ContainerRehrig Pacific Company · 2013 · 3 generations on0descendants
- K081821D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip)Global Pathogen Solutions, Inc. · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K964387 | Point of Use II Sharps-a-Gator | Graphic Controls Corp. | 1997 | — |
| 0 (this device) | K991612 | Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5G | Sterilogic Waste Systems, Inc. | 1999 | — |
| +1 | K020664 | Sterisharp 3-Gallon RSDC, Model RSDC3G | Sterilogic Waste Systems, Inc. | 2002 | — |
| +2 | K083511 | Enviro Sharp Solutions 3 | Industrial Water Solutions, Inc. | 2009 | — |
| +3 | K131087 | Sharpstank Reusable Sharps Container | Rehrig Pacific Company | 2013 | — |
| +2 | K081821 | D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip) | Global Pathogen Solutions, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K964387 | Point of Use II Sharps-a-GatorSummary page 1…N RSDC REUSABLE SHARPS DISPOSAL CONTAINER CLASS II - ACCESSORY DEVICE GRAPHICS CONTROLS - POINT-OF-USE II SHARPS-A-GATOR MAIL-DROP TORTUROUS PATH TUMBLER LID (510{k] #K964387) ROTONICS MANUFACTURING, INC. (RMI) ROTATIONALLY MOLDED PLASTIC REUSABLE SHARPS CONTAINER (510[k] #K964026) lof2 === Page 2 =… | 1997 |
| Kept off the family tree | K964026 | FDA’s K964026 is STP System - Saf Our OCR of the scanned summary read K964026, FDA’s number for STP System - Saf (Sage Products, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Rotonics Manufacturing, Inc. (RMI) Rotationally Molded Plastic…”. Kept off the family tree. Summary page 1…HARPS-A-GATOR MAIL-DROP TORTUROUS PATH TUMBLER LID (510{k] #K964387) ROTONICS MANUFACTURING, INC. (RMI) ROTATIONALLY MOLDED PLASTIC REUSABLE SHARPS CONTAINER (510[k] #K964026) lof2 807.92(4) DESCRIPTION: 807.92(5) 1L A9 )12 prar2q 2 REUSABLE PLASTIC SHARPS DISPOSAL CONTAINER; two com… | 1996 |
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K020664 | Sterisharp 3-Gallon RSDC, Model RSDC3G | 2002 | 3 |
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.
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™ 2.5 Gallon RSDC reusable containers are intended to be used 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 ultimate treatment and disposal of waste. Containers are of such a design and material as to withstand emptying, unloading, washing and disinfecting for reuse according to 49 CFR Sections 178.603, 173.4465(d), 173.465(e) and 178.608.
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/K991612 · printed Nov 4, 2026
Cite this page
510(k) Report. “K991612: Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5G.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K991612
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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