510(k) · Cleared
ClearedClip 'N'ject Reconstitution System (Clip 'N'ject
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
West Pharmaceutical Services, Inc. · LHI Set, I.V. Fluid Transfer
Cleared on Aug 5, 2004 as substantially equivalent to K010703 (Duoject Medical Systems, Inc., 2001) and 2 other predicates after a 44-day review. Its family tree reaches back 2 generations to 1989. 3 later devices descend from it.
- Decided
- Aug 5, 2004
- Review
- 44 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K894177 (1989). 5 ancestors in all. 3 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK894177 Needle*Less Drug Vial AdapterBaxter Healthcare Corp · 1989
- 1 generation backK963012 Bioject Needle-Free Vial Adapter (13MM)Bioject, Inc. · 1996
- This deviceK041691 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 · cites it directly · 1 of its ownK133097 E-Z LinkDuoject Medical Systems, Inc. · 2014
- Descendant · 2 generations on · 0 of its ownK161800 OnSite-IVPharmc, LLC · 2016
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K894177 | Needle*Less Drug Vial Adapter | Baxter Healthcare Corp | 1989 | — |
| −1 | K963012 | Bioject Needle-Free Vial Adapter (13MM) | Bioject, Inc. | 1996 | — |
| 0 (this device) | K041691 | Clip 'N'ject Reconstitution System (Clip 'N'ject | West Pharmaceutical Services, Inc. | 2004 | — |
| +1 | K070584 | Smart-Rod | Duoject Medical Systems, Inc. | 2008 | — |
| +1 | K133097 | E-Z Link | Duoject Medical Systems, Inc. | 2014 | — |
| +2 | K161800 | OnSite-IV | Pharmc, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K010703 | Inter-VialSummary page 1…stem is substantially equivalent to: > Inter - Vial that is legally marketed and distributed by Duoject Medical Systems Inc. pursuant to premarket notification K010703 > Needle-Free Adapter that is legally marketed and distributed by Bioject, Inc. pursuant to pursuant to premarket notif… | 2001 |
| * | K963012 | Bioject Needle-Free Vial Adapter (13MM)Summary page 1…o premarket notification K010703 > Needle-Free Adapter that is legally marketed and distributed by Bioject, Inc. pursuant to pursuant to premarket notification K963012; > Mixject that is legally marketed and distributed by Medimop Medical products Ltd. pursuant to premarket notification… | 1996 |
| * | K963583 | Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and… Our reading of the summary gave K963853, which is not a number in FDA’s lists. Corrected to the number with two digits swapped whose FDA name carries the summary’s words for the device, “Mixject”. | 1996 |
What descends from it? (3)
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?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 7.8 years on median.
- None of the 5 ancestors has a recall.
- 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 Clip'n'Ject Reconstitution System is a single use device intended to transfer diluent into a vial containing a lyophilized drug, mix the diluent and the lyophilized drug, and transfer the reconstituted drug into a standard syringe. The Clip'n'Ject Reconstitution System may be used by physicians, nurses, and other practitioners who routinely administer injections, or by patients and other individuals authorized by their physician to administer injections of prescribed medication.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K041691 · printed Nov 4, 2026
Cite this page
510(k) Report. “K041691: Clip 'N'ject Reconstitution System (Clip 'N'ject.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K041691
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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