510(k) · Cleared
ClearedOnSite-IV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Pharmc, LLC · LHI Set, I.V. Fluid Transfer
Cleared on Dec 6, 2016 as substantially equivalent to K133097 (Duoject Medical Systems, Inc., 2014) and 1 other predicate after a 159-day review. Its family tree reaches back 5 generations to 1989.
- Decided
- Dec 6, 2016
- Review
- 159 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K894177 (1989). 10 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK894177 Needle*Less Drug Vial AdapterBaxter Healthcare Corp · 1989
- 4 generations backK963012 Bioject Needle-Free Vial Adapter (13MM)Bioject, Inc. · 1996
- 3 generations backK041691 Clip 'N'ject Reconstitution System (Clip 'N'jectWest Pharmaceutical Services, Inc. · 2004
- 2 generations backK070584 Smart-RodDuoject Medical Systems, Inc. · 2008
- 1 generation backK133097 E-Z LinkDuoject Medical Systems, Inc. · 2014
- This deviceK161800 OnSite-IVPharmc, LLC · 2016
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K894177 | Needle*Less Drug Vial Adapter | Baxter Healthcare Corp | 1989 | — |
| −4 | K963012 | Bioject Needle-Free Vial Adapter (13MM) | Bioject, Inc. | 1996 | — |
| −3 | K041691 | Clip 'N'ject Reconstitution System (Clip 'N'ject | West Pharmaceutical Services, Inc. | 2004 | — |
| −2 | K070584 | Smart-Rod | Duoject Medical Systems, Inc. | 2008 | — |
| −1 | K133097 | E-Z Link | Duoject Medical Systems, Inc. | 2014 | — |
| 0 (this device) | K161800 | OnSite-IV | Pharmc, LLC | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1996 | 1 | 0 |
| 2001 | 1 | 0 |
| 2005 | 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 |
|---|---|---|---|
| * | K133097 | E-Z LinkSummary page 4…Regulation Name - Intravascular administration set Product Code LHI, Class-II PREDICATE DEVICE E-Z-Link – K133097 IV Fluid Transfer Pin - K925401 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: T… | 2014 |
| * | K925401 | IV Fluid Transfer PinSummary page 4…Product Code LHI, Class-II PREDICATE DEVICE E-Z-Link – K133097 IV Fluid Transfer Pin - K925401 DESCRIPTION OF THE DEVICE SUBJECT TO PREMARKET NOTIFICATION: The OnSite-IV™ device is a sterile, single use device that, throug… | 1993 |
What descends from it?
No later submission names this one as a predicate yet.
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 27 years and passes through 5 companies; a new generation was cleared every 5.9 years on median.
- 1 of the 10 ancestors has a recall of any class.
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. 2016, this device’s year, is highlighted.
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 OnSite-IV™ is a single use sterile device for the preparation and / or transfer of drugs from a standard pharmaceutical vial into an elastomeric pump or IV bag.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K161800 · printed Nov 6, 2026
Cite this page
510(k) Report. “K161800: OnSite-IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K161800
Report an extraction error
Are you the manufacturer?
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