510(k) · Cleared
ClearedSharps Safe 1.5 & Sharps Safe 2.0
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Dura-Vac Products · MMK Container, Sharps
Cleared on Aug 1, 1996 as substantially equivalent to K943892 (Devon Industries, Inc., 1994) after a 241-day review. Its family tree reaches back 1 generation to 1994. 3 later devices descend from it.
- Decided
- Aug 1, 1996
- Review
- 241 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K943892 (1994). 3 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK943892 Point of Use Sharps a GatorDevon Industries, Inc. · 1994
- This deviceK955514 Sharps Safe 1.5 & Sharps Safe 2.0Dura-Vac Products · 1996
- Descendant · cites it directly · 1 of its ownK990936 The VaultStik Stoppers, Inc. · 1999
- Descendant · 2 generations on · 0 of its ownK091690 Sharp ChuteHeathrow Scientific, LLC · 2009
- Descendant · cites it directly · 0 of its ownK081821 D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip)Global Pathogen Solutions, Inc. · 2008
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K943892 | Point of Use Sharps a Gator | Devon Industries, Inc. | 1994 | — |
| 0 (this device) | K955514 | Sharps Safe 1.5 & Sharps Safe 2.0 | Dura-Vac Products | 1996 | — |
| +1 | K990936 | The Vault | Stik Stoppers, Inc. | 1999 | — |
| +2 | K091690 | Sharp Chute | Heathrow Scientific, LLC | 2009 | — |
| +1 | K081821 | D.a.R.T. Pro Kit (D.a.R.T. Pro Handle and X-Tractor Tip) | Global Pathogen Solutions, Inc. | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 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 |
|---|---|---|---|
| * | K943892 | Point of Use Sharps a GatorSummary page 1…e - Sharps Container 80MMK 880.5570 Equivalent device being legally marketed: Trade name - Sharps A Gator Manufactured by: Devon Industries, Inc. 510K Approval Number: K943892 Description: The device is comprised of a 1.5 inch diameter tube (model 1.5), or a 2.0 diameter plastic tube (model 2.0). Secur… | 1994 |
What descends from it? (3)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
- Of its descendants, K990936 (Stik Stoppers, Inc., 1999) has gone furthest, with 1 descendant 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.
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?
Sharps Safes are designed to be used by Paramedics or Home Care Providers who need a small, portable and rugged sharps container which can be used in remote locations to dispose of contaminated 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/K955514 · printed Nov 4, 2026
Cite this page
510(k) Report. “K955514: Sharps Safe 1.5 & Sharps Safe 2.0.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K955514
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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