510(k) · Cleared
ClearedQ-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioject Medical Technologies, Inc. · LHI Set, I.V. Fluid Transfer
Cleared on Jan 14, 2005 after a 45-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 4 later devices descend from it.
- Decided
- Jan 14, 2005
- Review
- 45 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
4 later devices descend from it, 2 citing it directly.
- This deviceK043304 Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01Bioject Medical Technologies, Inc. · 2005
- Descendant · cites it directly · 2 of its ownK070584 Smart-RodDuoject Medical Systems, Inc. · 2008
- Descendant · 2 generations on · 1 of its ownK133097 E-Z LinkDuoject Medical Systems, Inc. · 2014
- Descendant · 3 generations on · 0 of its ownK161800 OnSite-IVPharmc, LLC · 2016
- Descendant · cites it directly · 0 of its ownK130179 MP Vial Adapter 13MMMedimop Medical Projects, Ltd. · 2013
Most influential descendants
Showing 4 of 4 · See all- K070584Smart-RodDuoject Medical Systems, Inc. · 2008 · cites it directly2descendants
- K133097E-Z LinkDuoject Medical Systems, Inc. · 2014 · 2 generations on1descendant
- K161800OnSite-IVPharmc, LLC · 2016 · 3 generations on0descendants
- K130179MP Vial Adapter 13MMMedimop Medical Projects, Ltd. · 2013 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043304 | Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01 | Bioject Medical Technologies, Inc. | 2005 | — |
| +1 | K070584 | Smart-Rod | Duoject Medical Systems, Inc. | 2008 | — |
| +2 | K133097 | E-Z Link | Duoject Medical Systems, Inc. | 2014 | — |
| +3 | K161800 | OnSite-IV | Pharmc, LLC | 2016 | — |
| +1 | K130179 | MP Vial Adapter 13MM | Medimop Medical Projects, Ltd. | 2013 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2013 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 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 LHI? 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 LHI device
- #1 K252987 ADRx™ Admixture Devicescore 12.4 · 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K041654 | Q.Cap Needle-Free Reconstitution 13mm Vial Adapter Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree |
What descends from it? (4)
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?
- Of its descendants, K070584 (Duoject Medical Systems, Inc., 2008) has gone furthest, with 2 descendants of its own.
How does its category compare?
All LHI devicesLHI Set, I.V. Fluid Transfer: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · LHI
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · LHI
196in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · LHI
1in 2024
Class I (6 since 2007) Class II/III not classified
Adverse event reports per year · LHI
1,334in 2025
MAUDE reports naming product code LHI, 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 | 3 | 89 | 1 | 18 |
| 2008 | 4 | 154 | 3 | 27 |
| 2009 | 8 | 95 | 1 | 37 |
| 2010 | 5 | 139 | 3 | 49 |
| 2011 | 3 | 99 | 12 | 155 |
| 2012 | 5 | 127 | 0 | 529 |
| 2013 | 4 | 102 | 3 | 154 |
| 2014 | 6 | 63 | 0 | 155 |
| 2015 | 3 | 99 | 0 | 128 |
| 2016 | 3 | 159 | 1 (1) | 219 |
| 2017 | 5 | 56 | 1 | 536 |
| 2018 | 1 | — | 3 (3) | 1,499 |
| 2019 | 4 | 247 | 1 | 1,634 |
| 2020 | 3 | 189 | 0 | 1,171 |
| 2021 | 3 | 396 | 0 | 933 |
| 2022 | 6 | 278 | 2 | 1,834 |
| 2023 | 5 | 90 | 2 (2) | 1,047 |
| 2024 | 9 | 166 | 1 | 1,270 |
| 2025 | 6 | 196 | 0 | 1,334 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
The Q.Cap Needle-Free Reconstitution 13mm Vial Adapter is intended to allow needle-free withdrawal, reconstitution and transfer of Repronex® (menotropins for injection, USP) and/or Bravelle® (urofollitropin for injection, purified) and/or Menopur® (menotropins for injection, USP) and diluent from vials into an injection syringe for administration.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043304 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043304: Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043304
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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