510(k) · Cleared
ClearedPoint of Use II Sharps-a-Gator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Graphic Controls Corp. · MMK Container, Sharps
Cleared on Mar 27, 1997 after a 143-day review. The FDA summary names its predicate without a number. 7 later devices descend from it.
- Decided
- Mar 27, 1997
- Review
- 143 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 3 citing it directly.
- This deviceK964387 Point of Use II Sharps-a-GatorGraphic Controls Corp. · 1997
- Descendant · cites it directly · 4 of its ownK991612 Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5GSterilogic Waste Systems, Inc. · 1999
- Descendant · 2 generations on · 3 of its ownK020664 Sterisharp 3-Gallon RSDC, Model RSDC3GSterilogic Waste Systems, Inc. · 2002
- Descendant · 3 generations on · 1 of its ownK083511 Enviro Sharp Solutions 3Industrial Water Solutions, Inc. · 2009
- Descendant · cites it directly · 1 of its ownK990936 The VaultStik Stoppers, Inc. · 1999
- Descendant · 4 generations on · 0 of its ownK131087 Sharpstank Reusable Sharps ContainerRehrig Pacific Company · 2013
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K991612Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5GSterilogic Waste Systems, Inc. · 1999 · cites it directly4descendants
- K020664Sterisharp 3-Gallon RSDC, Model RSDC3GSterilogic Waste Systems, Inc. · 2002 · 2 generations on3descendants
- K083511Enviro Sharp Solutions 3Industrial Water Solutions, Inc. · 2009 · 3 generations on1descendant
- K990936The VaultStik Stoppers, Inc. · 1999 · cites it directly1descendant
- K131087Sharpstank Reusable Sharps ContainerRehrig Pacific Company · 2013 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | 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 | — |
| +2 | K020664 | Sterisharp 3-Gallon RSDC, Model RSDC3G | Sterilogic Waste Systems, Inc. | 2002 | — |
| +3 | K083511 | Enviro Sharp Solutions 3 | Industrial Water Solutions, Inc. | 2009 | — |
| +1 | K990936 | The Vault | Stik Stoppers, Inc. | 1999 | — |
| +4 | K131087 | Sharpstank Reusable Sharps Container | Rehrig Pacific Company | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 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 |
|---|---|---|---|
| * | — | Point of Use Sharps-A-Gator Named without a submission number | |
| * | — | Sage In-Room and Sharpstar Disposal System Named without a submission number |
What descends from it? (7)
3 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, K991612 (Sterilogic Waste Systems, Inc., 1999) has gone furthest, with 4 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 Point of Use Il Sharps-A-Gator® will be used as a sharps container/disposal system. It can be used in any area requiring sharps collection prior to their final disposal. e.g. operating room, emergency room, patient room, pediatrics, doctor's office etc
The Point Of Use Il Sharps-A-Gator® is for single use only and must be disposed of after its maximum capacity level is reached.
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/K964387 · printed Nov 6, 2026
Cite this page
510(k) Report. “K964387: Point of Use II Sharps-a-Gator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K964387
Report an extraction error
Are you the manufacturer?
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