510(k) · Cleared
ClearedTiger Reusable Sharps Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
International Marketing Specialists, Inc. · MMK Container, Sharps
Cleared on Aug 6, 2021 as substantially equivalent to K153363 (Triumvirate Environmental, Inc., 2016) after a 270-day review. Its family tree reaches back 3 generations to 2000.
- Decided
- Aug 6, 2021
- Review
- 270 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K001337 (2000). 5 ancestors in all, the oldest K950897 (1995). No later device cites it as a predicate yet.
- Root · 3 generations backK001337 Daniels Sharpsmart Reusable Sharps ContainerThe Daniels Corp. · 2000
- 2 generations backK132007 Stericycle Sharps Management Service Reusable Sharps Container, 2…Stericycle, Inc. · 2013
- 1 generation backK153363 Red2Green Reusable Sharps ContainerTriumvirate Environmental, Inc. · 2016
- This deviceK203305 Tiger Reusable Sharps ContainerInternational Marketing Specialists, Inc. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K001337 | Daniels Sharpsmart Reusable Sharps Container | The Daniels Corp. | 2000 | — |
| −2 | K132007 | Stericycle Sharps Management Service Reusable Sharps Container, 2 Gallon, Red… | Stericycle, Inc. | 2013 | — |
| −1 | K153363 | Red2Green Reusable Sharps Container | Triumvirate Environmental, Inc. | 2016 | — |
| 0 (this device) | K203305 | Tiger Reusable Sharps Container | International Marketing Specialists, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 2 | 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 |
|---|---|---|---|
| * | K153363 | Red2Green Reusable Sharps ContainerSummary page 5…III. Predicate Device Information Manufacturer Predicate Device 510(k) Number Triumvirate Red2Green Reusable K153363 Environmental, Inc. Sharps Container K203305 Page 1 of 12 IV. D… | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 4 companies; a new generation was cleared every 5.0 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
Tiger Reusable Sharps Containers and accessories are intended to be used in healthcare facilities including nursing stations, medication carts, laboratories, dental offices, emergency rooms, surgical rooms, treatment rooms, emergency vehicles, veterinarian offices and other small quantity waste generators for the safe disposal, storage and transportation of hazardous sharps.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203305 · printed Nov 6, 2026
Cite this page
510(k) Report. “K203305: Tiger Reusable Sharps Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K203305
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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