510(k) · Cleared
ClearedPureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pureway Compliance, Inc. · MMK Container, Sharps
Cleared on Oct 14, 2025 as substantially equivalent to K151249 (Pureway Compliance, Inc., 2015) after a 118-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Oct 14, 2025
- Review
- 118 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K943134 (1994). No later device cites it as a predicate yet.
- Root · 4 generations backK943134 B-D Guardian Nestable Sharps CollectorsMed-Safe Systems, Inc. · 1994
- 3 generations backK112774 BD Recykleen Sharps CollectorsBecton, Dickinson and Company · 2012
- 2 generations backK132476 Sharps ContainerGrp & Associates · 2014
- 1 generation backK151249 Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2…Pureway Compliance, Inc. · 2015
- This deviceK251874 PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K943134 | B-D Guardian Nestable Sharps Collectors | Med-Safe Systems, Inc. | 1994 | — |
| −3 | K112774 | BD Recykleen Sharps Collectors | Becton, Dickinson and Company | 2012 | — |
| −2 | K132476 | Sharps Container | Grp & Associates | 2014 | — |
| −1 | K151249 | Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon… | Pureway Compliance, Inc. | 2015 | — |
| 0 (this device) | K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) | Pureway Compliance, Inc. | 2025 | — |
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 |
|---|---|---|---|
| * | K151249 | Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon, Pureway Sharps…Summary page 5…2 GALLON, PUREWAY SHARPS COLLECTOR 3 GALLON Premarket Notification NO. K151249 Device Classification Name Hypodermic single-lumen needle (CFR 880.5570) Product Code… | 2015 |
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 31 years and passes through 4 companies; a new generation was cleared every 10.1 years on median.
- None of the 4 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. 2025, 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 PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal(800011 800012, 800013) are single-use, disposable, non-sterile containers intended to be used for healthcare purposes for the safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets, and blood needles. The target population is trained healthcare professionals.
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/K251874 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251874: PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251874
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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