510(k) · Cleared
ClearedUltiguard Home Insulin Pen Needle Dispenser and Sharps Container
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ultimed, Inc. · MMK Container, Sharps
Cleared on Jun 3, 2008 as substantially equivalent to K021983 (Ultimed, Inc., 2002) after an 11-day review. Its family tree reaches back 1 generation to 2002.
- Decided
- Jun 3, 2008
- Review
- 11 days
- Class
- Class II
- Product code
- MMK
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K021983 (2002). No later device cites it as a predicate yet.
- Root · 1 generation backK021983 Ulti Guard Home Insulin Syringe ContainerUltimed, Inc. · 2002
- This deviceK081449 Ultiguard Home Insulin Pen Needle Dispenser and Sharps ContainerUltimed, Inc. · 2008
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K021983 | Ulti Guard Home Insulin Syringe Container | Ultimed, Inc. | 2002 | — |
| 0 (this device) | K081449 | Ultiguard Home Insulin Pen Needle Dispenser and Sharps Container | Ultimed, Inc. | 2008 | — |
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 |
|---|---|---|---|
| * | K021983 | Ulti Guard Home Insulin Syringe ContainerSummary page 1…ner is substantially equivalent in intended use, fuinction and basic composition to the currently marketed UltiGuard Home Insulin Syringe Dispenser and Sharps Container, K02 1983. Device Description The UltiGuard Home Insulin Pen Needle Dispenser and Sharps Container contains 100 insulin pen needles. Pen n… | 2002 |
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.
How does its category compare?
All MMK devicesMMK Container, Sharps: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 UltiGuard H6me Insulin Pen Needle Dispenser and Sharps Container by Ulti Med Inc. is intended to be used to transport, store and dispense insulin pen needles in the home. After use the used pen needle can be placed back into the container for safe storage and eventual disposal according to local regulations.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081449 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081449: Ultiguard Home Insulin Pen Needle Dispenser and Sharps Container.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081449
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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