510(k) · Cleared
ClearedHealthBeacon HB2 Sharps Bin
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Healthbeacon, Ltd. · MMK Container, Sharps
Cleared on May 11, 2018 as substantially equivalent to K132767 (Medline Industries, Inc., 2014) after a 245-day review. Its family tree reaches back 1 generation to 2014.
- Decided
- May 11, 2018
- Review
- 245 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K132767 (2014). No later device cites it as a predicate yet.
- Root · 1 generation backK132767 Medline Sharps ContainerMedline Industries, Inc. · 2014
- This deviceK172719 HealthBeacon HB2 Sharps BinHealthbeacon, Ltd. · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K132767 | Medline Sharps Container | Medline Industries, Inc. | 2014 | — |
| 0 (this device) | K172719 | HealthBeacon HB2 Sharps Bin | Healthbeacon, Ltd. | 2018 | — |
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 |
|---|---|---|---|
| * | K132767 | Medline Sharps ContainerSummary page 4…e/CFR Reference Class II, Accessory to hypodermic single lumen needle, 21 CFR 880.5570 Product Code: MMK Predicate Device Medline Sharps Container [K132767] Section V Page 1 of 7 Intended Use / Indications for Use The HealthBeaco… | 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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate K132767.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, 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 HealthBeacon HB2 Sharps Bin is intended for use by a single patient in the home setting. The HealthBeacon HB2 Sharps Bin comprises an outer enclosure that remains in the home. The outer enclosure contains a replaceable, single-use sharps bin that is intended to provide a receptacle for used, contaminated medical sharps. The single-use sharps bin also acts as an enclosure during transport of the used sharps to ultimate disposal. The HealthBeacon HB2…
Read the full statement (198 words)
The HealthBeacon HB2 Sharps Bin is intended for use by a single patient in the home setting. The HealthBeacon HB2 Sharps Bin comprises an outer enclosure that remains in the home. The outer enclosure contains a replaceable, single-use sharps bin that is intended to provide a receptacle for used, contaminated medical sharps. The single-use sharps bin also acts as an enclosure during transport of the used sharps to ultimate disposal.
The HealthBeacon HB2 Sharps Bin outer enclosure is a neutral gray color body with duck egg sides. The approximate dimensions are: width 9.5 inches by depth 9.4 inches and height 6.9 inches, with a weight of 5lb, including an empty sharps bin.
The inner, single-use sharps bin has a yellow semi-translucent body with a blue lid. The approximate dimensions of the bin are: width 9 inches by depth 7 inches and height of 4.5 inches. The gross volume is 2.4 US quarts, with an empty weight of 110z
The outer enclosure has a trap door to allow the used sharps to be deposited into the inner sharps bin. The aperture of the trap door, and thus the maximum size of a used sharp, is 6.5 by 1 inches.
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/K172719 · printed Nov 6, 2026
Cite this page
510(k) Report. “K172719: HealthBeacon HB2 Sharps Bin.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K172719
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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