510(k) · Cleared
ClearedRobertsite Vial Adapter, Model 245700021
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Halkey-Roberts Corp. · LHI Set, I.V. Fluid Transfer
Cleared on Mar 23, 2004 as substantially equivalent to K013087 (Alaris Medical Systems, Inc., 2001) after a 13-day review. Its family tree reaches back 2 generations to 1979. 2 of the 9 devices in its family, counting itself, have a Class I recall. 5 later devices descend from it.
- Decided
- Mar 23, 2004
- Review
- 13 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K790472 (1979). 3 ancestors in all. 5 later devices descend from it, 3 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 2 generations backK790472 Burron Vented NeedleNational Patent Development Corp. · 1979
- 1 generation backK013087 Single Dose Dispensing Pin, Model 2201Alaris Medical Systems, Inc. · 2001
- This deviceK040634 Robertsite Vial Adapter, Model 245700021Halkey-Roberts Corp. · 2004
- Descendant · cites it directly · 2 of its ownK072759 VIAL2BAGMedimop Medical Projects, Ltd. · 2007 · Recalled (Class I)
- Descendant · 2 generations on · 1 of its ownK140730 VIAL2BAG Direct ConnectMedimop Medical Projects, Ltd. · 2014 · Recalled
- Descendant · 3 generations on · 0 of its ownK170095 Vial2Bag Direct ConnectMedimop Medical Project, Ltd. · 2017 · Recalled (Class I)
- Descendant · cites it directly · 0 of its ownK072511 Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MMMedimop Medical Projects, Ltd. · 2007
- Descendant · cites it directly · 0 of its ownK061143 Robertsite StopcockHalkey-Roberts Corp. · 2006
Class I recalls in this family
Most influential descendants
Showing 5 of 5 · See all- K072759VIAL2BAGMedimop Medical Projects, Ltd. · 2007 · cites it directly2descendants
- K140730VIAL2BAG Direct ConnectMedimop Medical Projects, Ltd. · 2014 · 2 generations on1descendant
- K170095Vial2Bag Direct ConnectMedimop Medical Project, Ltd. · 2017 · 3 generations on0descendants
- K072511Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MMMedimop Medical Projects, Ltd. · 2007 · cites it directly0descendants
- K061143Robertsite StopcockHalkey-Roberts Corp. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K790472 | Burron Vented Needle | National Patent Development Corp. | 1979 | — |
| −1 | K013087 | Single Dose Dispensing Pin, Model 2201 | Alaris Medical Systems, Inc. | 2001 | — |
| 0 (this device) | K040634 | Robertsite Vial Adapter, Model 245700021 | Halkey-Roberts Corp. | 2004 | — |
| +1 | K072759 | VIAL2BAG | Medimop Medical Projects, Ltd. | 2007 | Class I |
| +2 | K140730 | VIAL2BAG Direct Connect | Medimop Medical Projects, Ltd. | 2014 | 1 |
| +3 | K170095 | Vial2Bag Direct Connect | Medimop Medical Project, Ltd. | 2017 | Class I |
| +1 | K072511 | Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MM | Medimop Medical Projects, Ltd. | 2007 | — |
| +1 | K061143 | Robertsite Stopcock | Halkey-Roberts Corp. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2007 | 2 | 1 |
| 2014 | 1 | 0 |
| 2017 | 1 | 1 |
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.
2 devices in this family have a Class I recall. 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K013087 | Single Dose Dispensing Pin, Model 2201Summary page 2…bstantially equivalent to the comparison predicate device, the Alaris Smartsite® Needle-free Vial Access Device system cleared for market on November 13, 2001 (K013087). H. Performance Data Testing was performed using the FDA's Draft October 12, 2000 "Guidance on 510(k) submissions… | 2001 |
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? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 22.6 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K072759 (Medimop Medical Projects, Ltd., 2007) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K013087.
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?
Robertsite* Vial Adapter is indicated to allow multiple needleless access to an injection medication vial for the purpose of facilitating the withdrawal or addition of drugs/solutions from or to the vial.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K040634 · printed Nov 6, 2026
Cite this page
510(k) Report. “K040634: Robertsite Vial Adapter, Model 245700021.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K040634
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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