510(k) · Cleared
ClearedPureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon, Pureway Sharps Collector 3 Gallon
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 Sep 4, 2015 as substantially equivalent to K132476 (Grp & Associates, 2014) after a 115-day review. Its family tree reaches back 3 generations to 1994. 1 later device descends from it.
- Decided
- Sep 4, 2015
- Review
- 115 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K943134 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK943134 B-D Guardian Nestable Sharps CollectorsMed-Safe Systems, Inc. · 1994
- 2 generations backK112774 BD Recykleen Sharps CollectorsBecton, Dickinson and Company · 2012
- 1 generation backK132476 Sharps ContainerGrp & Associates · 2014
- This deviceK151249 Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2…Pureway Compliance, Inc. · 2015
- Descendant · cites it directly · 0 of its ownK251874 PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc. · 2025
Most influential descendants
Showing 1 of 1 · See all- K251874PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013)Pureway Compliance, Inc. · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K943134 | B-D Guardian Nestable Sharps Collectors | Med-Safe Systems, Inc. | 1994 | — |
| −2 | K112774 | BD Recykleen Sharps Collectors | Becton, Dickinson and Company | 2012 | — |
| −1 | K132476 | Sharps Container | Grp & Associates | 2014 | — |
| 0 (this device) | K151249 | Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon… | Pureway Compliance, Inc. | 2015 | — |
| +1 | K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) | Pureway Compliance, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 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 |
|---|---|---|---|
| * | K132476 | Sharps ContainerSummary page 4…on Class II device Classification Panel General Hospital d. Predicate Device GRP Sharps Container 510(k) number K132476 e. Device -Description The PureWay® Sharps Collector container is blow molded with High Density Polyethylene p… | 2014 |
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 |
|---|---|---|---|
| K251874 | PureWay Sharps Container 1-Gal, 2-Gal, 3-Gal (800011 800012, 800013) | 2025 | 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 21 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K251874 (Pureway Compliance, Inc., 2025) has gone furthest, with 0 descendants 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. 2015, 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 Collector Container is a disposable infectious waste container in 1.2 gallon, 2 gallon and 3 gallon sizes, intended for use in a healthcare setting. The PureWay® Sharps Collector Container will be ultimately destroyed through incineration. The empty device, as it sits, is a red container that measures 10.75” x 6” x 7.27” and weighs 7oz. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended…
Read the full statement (262 words)
The PureWay® Sharps Collector Container is a disposable infectious waste container in 1.2 gallon, 2 gallon and 3 gallon sizes, intended for use in a healthcare setting. The PureWay® Sharps Collector Container will be ultimately destroyed through incineration.
The empty device, as it sits, is a red container that measures 10.75” x 6” x 7.27” and weighs 7oz. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
The empty device, as it sits, is a red container that measures 10.75” x 6” x 11.15” and weighs 1lb 1oz. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
The empty device, as it sits, is a red container that measures 10.75” x 6” x 15.73” and weighs 2 lbs. The aperture includes an insert which limits the opening to 1.25 inches in diameter. The intended use of the vertical entry, single use, sharps containers, is to provide a receptacle for used, contaminated medical sharps, and for enclosure during transport to ultimate disposal. The container is intended to be used in a healthcare setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K151249 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151249: Pureway Sharps Collector 1.2 Gallon, Pureway Sharps Collector 2 Gallon, Pureway Sharps Collector 3 Gallon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151249
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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