510(k) · Cleared
ClearedDemolizer #47 One-Gallon Point of Generation Sharps Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Thermal Waste Technology, Inc. · MMK Container, Sharps
Cleared on Sep 30, 1998 as substantially equivalent to K925816 (Post Medical, Inc., 1994) and 1 other predicate after a 54-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Sep 30, 1998
- Review
- 54 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K925816 (1994). 2 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK925816 Sharps Containment SystemPost Medical, Inc. · 1994
- This deviceK982781 Demolizer #47 One-Gallon Point of Generation Sharps ContainerThermal Waste Technology, Inc. · 1998
- Descendant · cites it directly · 1 of its ownK131708 Bwcsh-1 Sharps ContainerBradford Wright Companies, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK182235 OnSite Waste Sharps ContainerBluestone Medical, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK123807 SharpscanMedical Engineering Development Solutions, Inc. · 2013
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K925816 | Sharps Containment System | Post Medical, Inc. | 1994 | — |
| 0 (this device) | K982781 | Demolizer #47 One-Gallon Point of Generation Sharps Container | Thermal Waste Technology, Inc. | 1998 | — |
| +1 | K131708 | Bwcsh-1 Sharps Container | Bradford Wright Companies, Inc. | 2014 | — |
| +2 | K182235 | OnSite Waste Sharps Container | Bluestone Medical, Inc. | 2019 | — |
| +1 | K123807 | Sharpscan | Medical Engineering Development Solutions, Inc. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2019 | 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 |
|---|---|---|---|
| * | K925816 | Sharps Containment SystemSummary page 1…eneration Sharps Container is substantially equivalent to the 1.0 Gallon Leaktight Locking Top Translucent Red Sharps Disposal Container marketed by Post Medical, Inc. (#K925816), and to the 5-Quart Round Sharps Container marketed by Sage Products, Inc. (#K943659). General Description The Demolizer # 47… | 1994 |
| * | K943659 | Ancillary and Large Volume Sharps Disposal ContainersSummary page 1…king Top Translucent Red Sharps Disposal Container marketed by Post Medical, Inc. (#K925816), and to the 5-Quart Round Sharps Container marketed by Sage Products, Inc. (#K943659). General Description The Demolizer # 47 One-Gallon Point of Generation Sharps Container is a single use, non-sterile, disposab… | 1995 |
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?
- None of the 2 ancestors has a recall.
- Of its descendants, K131708 (Bradford Wright Companies, Inc., 2014) 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?
This device is intended for the disposal of various-sized contaminated medical sharps (including needles, syringes, slides, and ampoules) in clinical and laboratory healthcare settings.
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/K982781 · printed Nov 4, 2026
Cite this page
510(k) Report. “K982781: Demolizer #47 One-Gallon Point of Generation Sharps Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K982781
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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