510(k) · Cleared
ClearedNeedle*Less Drug Vial Adapter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FMF Syringe, Piston
Cleared on Sep 12, 1989 after an 89-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 7 later devices descend from it.
- Decided
- Sep 12, 1989
- Review
- 89 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
7 later devices descend from it, 2 citing it directly.
- This deviceK894177 Needle*Less Drug Vial AdapterBaxter Healthcare Corp · 1989
- Descendant · cites it directly · 5 of its ownK963012 Bioject Needle-Free Vial Adapter (13MM)Bioject, Inc. · 1996
- Descendant · 2 generations on · 3 of its ownK041691 Clip 'N'ject Reconstitution System (Clip 'N'jectWest Pharmaceutical Services, Inc. · 2004
- Descendant · 2 generations on · 2 of its ownK070584 Smart-RodDuoject Medical Systems, Inc. · 2008
- Descendant · 3 generations on · 1 of its ownK133097 E-Z LinkDuoject Medical Systems, Inc. · 2014
- Descendant · 4 generations on · 0 of its ownK161800 OnSite-IVPharmc, LLC · 2016
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K963012Bioject Needle-Free Vial Adapter (13MM)Bioject, Inc. · 1996 · cites it directly5descendants
- K041691Clip 'N'ject Reconstitution System (Clip 'N'jectWest Pharmaceutical Services, Inc. · 2004 · 2 generations on3descendants
- K070584Smart-RodDuoject Medical Systems, Inc. · 2008 · 2 generations on2descendants
- K133097E-Z LinkDuoject Medical Systems, Inc. · 2014 · 3 generations on1descendant
- K161800OnSite-IVPharmc, LLC · 2016 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894177 | Needle*Less Drug Vial Adapter | Baxter Healthcare Corp | 1989 | — |
| +1 | K963012 | Bioject Needle-Free Vial Adapter (13MM) | Bioject, Inc. | 1996 | — |
| +2 | K041691 | Clip 'N'ject Reconstitution System (Clip 'N'ject | West Pharmaceutical Services, Inc. | 2004 | — |
| +2 | K070584 | Smart-Rod | Duoject Medical Systems, Inc. | 2008 | — |
| +3 | K133097 | E-Z Link | Duoject Medical Systems, Inc. | 2014 | — |
| +4 | K161800 | OnSite-IV | Pharmc, LLC | 2016 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2008 | 1 | 0 |
| 2014 | 1 | 0 |
| 2016 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FMF? 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (7)
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, K963012 (Bioject, Inc., 1996) has gone furthest, with 5 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
https://510kreport.com/device/K894177 · printed Nov 5, 2026
Cite this page
510(k) Report. “K894177: Needle*Less Drug Vial Adapter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K894177
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026