510(k) · Cleared
ClearedPromisemed Sharps container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Promisemed Hangzhou Meditech Co., Ltd. · MMK Container, Sharps
Cleared on Nov 17, 2021 as substantially equivalent to K190240 (International Marketing Specialists, Inc., 2019) after a 149-day review. Its family tree reaches back 3 generations to 2014.
- Decided
- Nov 17, 2021
- Review
- 149 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K132767 (2014). No later device cites it as a predicate yet.
- Root · 3 generations backK132767 Medline Sharps ContainerMedline Industries, Inc. · 2014
- 2 generations backK143693 Medline Sharps ContainersMedline Industries, Inc. · 2015
- 1 generation backK190240 Tiger Sharps ContainersInternational Marketing Specialists, Inc. · 2019
- This deviceK211890 Promisemed Sharps containerPromisemed Hangzhou Meditech Co., Ltd. · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K132767 | Medline Sharps Container | Medline Industries, Inc. | 2014 | — |
| −2 | K143693 | Medline Sharps Containers | Medline Industries, Inc. | 2015 | — |
| −1 | K190240 | Tiger Sharps Containers | International Marketing Specialists, Inc. | 2019 | — |
| 0 (this device) | K211890 | Promisemed Sharps container | Promisemed Hangzhou Meditech Co., Ltd. | 2021 | — |
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 |
|---|---|---|---|
| * | K190240 | Tiger Sharps ContainersSummary page 4…lassification name: Container, Sharps Regulation Number: 21 CFR 880.5570 Device Class: Class II Product Code: MMK 4 Identification of Predicate Device K190240 Tiger Sharps Containers 7-1 Sharps Container… | 2019 |
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 7 years and passes through 3 companies; a new generation was cleared every 2.5 years on median.
- None of the 3 ancestors has a recall.
- 3 other devices also cite its predicate K190240.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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?
It is intended to be used for health care purposes for safe disposal of hazardous sharps such as hypodermic needles, syringes, lancets and blood needles.
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/K211890 · printed Nov 4, 2026
Cite this page
510(k) Report. “K211890: Promisemed 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/K211890
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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