510(k) · Cleared
ClearedBioject Needle-Free Vial Adapter (13MM)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Bioject, Inc. · LHI Set, I.V. Fluid Transfer
Cleared on Oct 15, 1996 as substantially equivalent to K894177 (Baxter Healthcare Corp, 1989) and 1 other predicate after a 74-day review. Its family tree reaches back 1 generation to 1989. 5 later devices descend from it.
- Decided
- Oct 15, 1996
- Review
- 74 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K894177 (1989). 2 ancestors in all. 5 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK894177 Needle*Less Drug Vial AdapterBaxter Healthcare Corp · 1989
- This deviceK963012 Bioject Needle-Free Vial Adapter (13MM)Bioject, Inc. · 1996
- Descendant · cites it directly · 3 of its ownK041691 Clip 'N'ject Reconstitution System (Clip 'N'jectWest Pharmaceutical Services, Inc. · 2004
- 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 ownK041564 Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01Bioject Medical Technologies, Inc. · 2004
Most influential descendants
Showing 5 of 5 · See all- K041691Clip 'N'ject Reconstitution System (Clip 'N'jectWest Pharmaceutical Services, Inc. · 2004 · cites it directly3descendants
- 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
- K041564Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01Bioject Medical Technologies, Inc. · 2004 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K894177 | Needle*Less Drug Vial Adapter | Baxter Healthcare Corp | 1989 | — |
| 0 (this device) | K963012 | Bioject Needle-Free Vial Adapter (13MM) | Bioject, Inc. | 1996 | — |
| +1 | K041691 | Clip 'N'ject Reconstitution System (Clip 'N'ject | West Pharmaceutical Services, Inc. | 2004 | — |
| +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 | K041564 | Q-Cap Needle-Free Reconstitution 13MM Vial Adapter, Model 6100-01 | Bioject Medical Technologies, Inc. | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 2 | 0 |
| 2008 | 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? (2)
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 |
|---|---|---|---|
| * | K894177 | Needle*Less Drug Vial AdapterSummary page 1…n Name: Needle-Free Fluid Transfer Device Classification Name: Accessory to a syringe, 21 CFR 880.5860 (a)(3) Predicate Devices: Baxter Needle*Less™ Drug Vial Adapter (K894177) Abbott LifeShield™ Vial Adapter (K920737) (a)(4) Device Description: The Bioject Needle-Free Vial Adapter is a device which pro… | 1989 |
| * | K920737 | Lifeshield Vial AdapterSummary page 1…Classification Name: Accessory to a syringe, 21 CFR 880.5860 (a)(3) Predicate Devices: Baxter Needle*Less™ Drug Vial Adapter (K894177) Abbott LifeShield™ Vial Adapter (K920737) (a)(4) Device Description: The Bioject Needle-Free Vial Adapter is a device which provides single access to 13 mm drug vials fo… | 1992 |
What descends from it? (5)
3 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?
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 intended use of the Bioject Needle-Free Vial Adapter is to allow single access to 13 mm drug vials for withdrawal of medications, withdrawal and transfer of diluents, and reconstitution and withdrawal of medications, without the use of needles. The Bioject Needle-Free Vial Adapter may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physicians to administer injections of prescribed medication.
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/K963012 · printed Nov 4, 2026
Cite this page
510(k) Report. “K963012: Bioject Needle-Free Vial Adapter (13MM).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K963012
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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