510(k) · Cleared
ClearedEnviro Sharp Solutions 3
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Industrial Water Solutions, Inc. · MMK Container, Sharps
Cleared on Mar 3, 2009 as substantially equivalent to K953797 (Bemis Mfg. Co., 1995) and 1 other predicate after a 97-day review. Its family tree reaches back 3 generations to 1997. 1 later device descends from it.
- Decided
- Mar 3, 2009
- Review
- 97 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K964387 (1997). 5 ancestors in all, the oldest K931664 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK964387 Point of Use II Sharps-a-GatorGraphic Controls Corp. · 1997
- 2 generations backK991612 Sterisharp 2.5-Gallon RSDC, Model #RSDC2.5GSterilogic Waste Systems, Inc. · 1999
- 1 generation backK020664 Sterisharp 3-Gallon RSDC, Model RSDC3GSterilogic Waste Systems, Inc. · 2002
- This deviceK083511 Enviro Sharp Solutions 3Industrial Water Solutions, Inc. · 2009
- Descendant · cites it directly · 0 of its ownK131087 Sharpstank Reusable Sharps ContainerRehrig Pacific Company · 2013
Most influential descendants
Showing 1 of 1 · See all- K131087Sharpstank Reusable Sharps ContainerRehrig Pacific Company · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K964387 | Point of Use II Sharps-a-Gator | Graphic Controls Corp. | 1997 | — |
| −2 | 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 | — |
| 0 (this device) | K083511 | Enviro Sharp Solutions 3 | Industrial Water Solutions, Inc. | 2009 | — |
| +1 | K131087 | Sharpstank Reusable Sharps Container | Rehrig Pacific Company | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K953797 | Sharps Disposal ContainersSummary page 2…to the StcriNlhrp ' 3, and uses the Bemnis Sharp SentinallO T (5 10k)#K953797 lid thai is a semi-transparent naural colored polypropylene mail drop. torturous path tumbler lid. It is injection moldcd and va… | 1995 |
| * | K020664 | Sterisharp 3-Gallon RSDC, Model RSDC3GSummary page 1…appromed under $10(k) F,953797. EQUIVALENT DEVICE/2: SteriSharp m 3 Gallon RSDC (510(k) 4K020664 CONTAINER. BASE: Thc bottom portion oftha unit (the "container") is a roillable polyethylenc cavity… | 2002 |
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 |
|---|---|---|---|
| K131087 | Sharpstank Reusable Sharps Container | 2013 | 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?
- The line of descent spans 12 years and passes through 3 companies; a new generation was cleared every 3.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K131087 (Rehrig Pacific Company, 2013) 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. 2009, 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?
The container is intended for use by healthcare providers, such as hospitals, laboratories,
medical clinics, veterinary clinics and other facilities where needles are generated. The
container is designed to safely contain sharps prior to removal from the generating
facility, during transportation and until ultimate treatment and disposal of the sharps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083511 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083511: Enviro Sharp Solutions 3.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083511
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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