510(k) · Cleared
ClearedOnSite Waste Sharps Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bluestone Medical, Inc. · MMK Container, Sharps
Cleared on May 20, 2019 as substantially equivalent to K131708 (Bradford Wright Companies, Inc., 2014) after a 276-day review. Its family tree reaches back 3 generations to 1994.
- Decided
- May 20, 2019
- Review
- 276 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K925816 (1994). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK925816 Sharps Containment SystemPost Medical, Inc. · 1994
- 2 generations backK982781 Demolizer #47 One-Gallon Point of Generation Sharps ContainerThermal Waste Technology, Inc. · 1998
- 1 generation backK131708 Bwcsh-1 Sharps ContainerBradford Wright Companies, Inc. · 2014
- This deviceK182235 OnSite Waste Sharps ContainerBluestone Medical, Inc. · 2019
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K925816 | Sharps Containment System | Post Medical, Inc. | 1994 | — |
| −2 | 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 | — |
| 0 (this device) | K182235 | OnSite Waste Sharps Container | Bluestone Medical, Inc. | 2019 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 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? (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 |
|---|---|---|---|
| * | K131708 | Bwcsh-1 Sharps ContainerSummary page 5…lass Il Classification: panel: General Hospital Legally Marketed Predicate Device: Company Product description 510(k) # Bradford Wright Companies, Demolizer Il Sharps K131708 (Primary Predicate) Inc. Container 6. Intended use / Indication for Use: Bluestone Medical, Inc. OWTSH-| Sharps Container is a… | 2014 |
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 25 years and passes through 4 companies; a new generation was cleared every 5.2 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. 2019, 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?
Bluestone Medical, Inc. OWTSH-I Sharps Container is a single- use, disposable, non-sterile container intended to be used for health-care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles. The target population is for qualified personnel in health care facilities and in other facilities in which medical sharps may be used. The container is intended to be used in areas where there is no unsupervised patient access.
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/K182235 · printed Nov 4, 2026
Cite this page
510(k) Report. “K182235: OnSite Waste 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/K182235
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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