510(k) · Cleared
ClearedThe Vault
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Stik Stoppers, Inc. · FMI Needle, Hypodermic, Single Lumen
Cleared on May 18, 1999 as substantially equivalent to K955514 (Dura-Vac Products, 1996) and 2 other predicates after a 60-day review. Its family tree reaches back 2 generations to 1994. 1 later device descends from it.
- Decided
- May 18, 1999
- Review
- 60 days
- Class
- Class II
- Product code
- FMI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K943892 (1994). 4 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK943892 Point of Use Sharps a GatorDevon Industries, Inc. · 1994
- 1 generation backK955514 Sharps Safe 1.5 & Sharps Safe 2.0Dura-Vac Products · 1996
- This deviceK990936 The VaultStik Stoppers, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK091690 Sharp ChuteHeathrow Scientific, LLC · 2009
Most influential descendants
Showing 1 of 1 · See all- K091690Sharp ChuteHeathrow Scientific, LLC · 2009 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K943892 | Point of Use Sharps a Gator | Devon Industries, Inc. | 1994 | — |
| −1 | K955514 | Sharps Safe 1.5 & Sharps Safe 2.0 | Dura-Vac Products | 1996 | — |
| 0 (this device) | K990936 | The Vault | Stik Stoppers, Inc. | 1999 | — |
| +1 | K091690 | Sharp Chute | Heathrow Scientific, LLC | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 FMI? 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 FMI device
- #1 K252886 Pen Needlescore 14.5 · 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? (3)
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 |
|---|---|---|---|
| * | K955514 | Sharps Safe 1.5 & Sharps Safe 2.0Summary page 2…bright red color to meet OSHA standards for warning of biohazard danger. 4. Substantial Equivalence A. Predicate Devices for Stik Stoppers , The VAULT Sharp-Safe 1.5 K955514 Sharps-a-Gator K964387 Sharp Shuttle K972279 B. Rationale Discussion The side by side comparisons show the equivalence of all f… | 1996 |
| * | K964387 | Point of Use II Sharps-a-GatorSummary page 2…et OSHA standards for warning of biohazard danger. 4. Substantial Equivalence A. Predicate Devices for Stik Stoppers , The VAULT Sharp-Safe 1.5 K955514 Sharps-a-Gator K964387 Sharp Shuttle K972279 B. Rationale Discussion The side by side comparisons show the equivalence of all four products. All four… | 1997 |
| * | K972279 | Sharps ShuttleSummary page 2…warning of biohazard danger. 4. Substantial Equivalence A. Predicate Devices for Stik Stoppers , The VAULT Sharp-Safe 1.5 K955514 Sharps-a-Gator K964387 Sharp Shuttle K972279 B. Rationale Discussion The side by side comparisons show the equivalence of all four products. All four are plastic , disposab… | 1997 |
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 |
|---|---|---|---|
| K091690 | Sharp Chute | 2009 | 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 5 years and passes through 3 companies; a new generation was cleared every 2.8 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K091690 (Heathrow Scientific, LLC, 2009) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K955514.
How does its category compare?
All FMI devicesFMI Needle, Hypodermic, Single Lumen: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMI
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMI
141in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMI
1in 2024
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · FMI
2,424in 2025
MAUDE reports naming product code FMI, 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 | 15 | 71 | 2 | 208 |
| 2008 | 10 | 85 | 4 | 177 |
| 2009 | 7 | 177 | 3 | 263 |
| 2010 | 15 | 119 | 79 | 249 |
| 2011 | 12 | 113 | 5 | 240 |
| 2012 | 17 | 107 | 1 | 215 |
| 2013 | 11 | 87 | 1 | 255 |
| 2014 | 14 | 155 | 3 | 287 |
| 2015 | 10 | 89 | 1 | 567 |
| 2016 | 20 | 217 | 0 | 941 |
| 2017 | 9 | 253 | 16 | 1,547 |
| 2018 | 20 | 176 | 0 | 2,398 |
| 2019 | 12 | 186 | 5 | 4,896 |
| 2020 | 11 | 263 | 3 | 4,245 |
| 2021 | 18 | 143 | 7 | 4,532 |
| 2022 | 23 | 189 | 0 | 4,885 |
| 2023 | 18 | 112 | 2 | 4,986 |
| 2024 | 3 | 90 | 1 | 4,053 |
| 2025 | 11 | 141 | 0 | 2,424 |
| 2026 | 12 | 119 | 1 (1) | — |
What is it indicated for?
The Vault is a single-use, disposable, non-sterile sharps transport container intended to be used by Paramedics and EMT’s in their medical jump kits where larger sharps containers are not conveniently accessible. Its function is to be available for portable sharps containment as an alternative to using non-sharps containers or resheathing a needle with its original protective cover.
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/K990936 · printed Nov 4, 2026
Cite this page
510(k) Report. “K990936: The Vault.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K990936
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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