510(k) · Cleared
ClearedBwcsh-1 Sharps Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bradford Wright Companies, Inc. · MMK Container, Sharps
Cleared on Mar 10, 2014 as substantially equivalent to K982781 (Thermal Waste Technology, Inc., 1998) and 1 other predicate after a 272-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- Mar 10, 2014
- Review
- 272 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K925816 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK925816 Sharps Containment SystemPost Medical, Inc. · 1994
- 1 generation backK982781 Demolizer #47 One-Gallon Point of Generation Sharps ContainerThermal Waste Technology, Inc. · 1998
- This deviceK131708 Bwcsh-1 Sharps ContainerBradford Wright Companies, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK182235 OnSite Waste Sharps ContainerBluestone Medical, Inc. · 2019
Most influential descendants
Showing 1 of 1 · See all- K182235OnSite Waste Sharps ContainerBluestone Medical, Inc. · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K925816 | Sharps Containment System | Post Medical, Inc. | 1994 | — |
| −1 | K982781 | Demolizer #47 One-Gallon Point of Generation Sharps Container | Thermal Waste Technology, Inc. | 1998 | — |
| 0 (this device) | K131708 | Bwcsh-1 Sharps Container | Bradford Wright Companies, Inc. | 2014 | — |
| +1 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K982781 | Demolizer #47 One-Gallon Point of Generation Sharps ContainerSummary page 2…width at the top, 4.75 inches deep and 8.25 inches in height. BWCSH- I sharps container weighs 1.075 pounds when empty. Predicate Device: 5 10(k) Number: K982781I Trade Name of Device: Demolizer #47 1 Gal. Point of Generation Shamps Container Common Name: Sharps Con… | 1998 |
| * | K943575 | B-D Guardian Nestable Sharps CollectorsSummary page 2…hermal Waste K982781 #47 I Gallon Point of Technologies, Inc. Generation Sharps Container B-D Guardian TM B~ecton Dickinson & Co. K 943575 Nestable Sharps Collectors BWCSH-1 Sharps Container Revision 4… | 1994 |
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 |
|---|---|---|---|
| K182235 | OnSite Waste Sharps Container | 2019 | 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 20 years and passes through 3 companies; a new generation was cleared every 15.4 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K182235 (Bluestone Medical, Inc., 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K982781.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 BWCSH-l sharps container has a one-gallon fill line capacity that is intended to be used for the safe disposal of hazardous sharps. The BWCSH- I sharps container ismetallic canister finted with thermal plastic top and has a orange-red biohazard label adhered to the containers with till line printed on the front. The BWCSH-lI device is for single use, disposable and is not a secondary container. BWCSH-l sharps container dimensions are 10.5 inches in width at the top, 4.75 inches deep and 8.25 inches in height. BWCSH-l sharps container weighs 1.075 pounds when empty.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131708 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131708: Bwcsh-1 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/K131708
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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