510(k) · Cleared
ClearedSwabable Vial Adapter 13MM, Swabable Vial Adapter 20MM
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medimop Medical Projects, Ltd. · LHI Set, I.V. Fluid Transfer
Cleared on Dec 13, 2007 as substantially equivalent to K040634 (Halkey-Roberts Corp., 2004) and 1 other predicate after a 98-day review. Its family tree reaches back 3 generations to 1979.
- Decided
- Dec 13, 2007
- Review
- 98 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K790472 (1979). 11 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK790472 Burron Vented NeedleNational Patent Development Corp. · 1979
- 2 generations backK013087 Single Dose Dispensing Pin, Model 2201Alaris Medical Systems, Inc. · 2001
- 1 generation backK040634 Robertsite Vial Adapter, Model 245700021Halkey-Roberts Corp. · 2004
- This deviceK072511 Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MMMedimop Medical Projects, Ltd. · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K790472 | Burron Vented Needle | National Patent Development Corp. | 1979 | — |
| −2 | K013087 | Single Dose Dispensing Pin, Model 2201 | Alaris Medical Systems, Inc. | 2001 | — |
| −1 | K040634 | Robertsite Vial Adapter, Model 245700021 | Halkey-Roberts Corp. | 2004 | — |
| 0 (this device) | K072511 | Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MM | Medimop Medical Projects, Ltd. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1993 | 1 | 0 |
| 1994 | 1 | 0 |
| 1996 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 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 |
|---|---|---|---|
| * | K040634 | Robertsite Vial Adapter, Model 245700021Summary page 1…ice name: Same as Trade name Predicate devices: ROBERTSITE VIAL ADAPTER 510(k) No. K040634 Halkey-Roberts SMARTSITE VENTED VIAL ACCESS… | 2004 |
| * | K052790 | Smartsite Vented Vial Access Device, Model TBDSummary page 1…Halkey-Roberts SMARTSITE VENTED VIAL ACCESS DEVICE 510(k) No. K052790 Cardinal I lealthcare - Alaris Products Manufacturer: M… | 2005 |
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 28 years and passes through 4 companies; a new generation was cleared every 3.7 years on median.
- 3 of the 11 ancestors have a recall of any class.
- 2 other devices also cite its predicate K040634.
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. 2007, 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 Swabable Vial Adapter is indicated to allow multiple needleless accesses to an injection medication vial for the purpose of facilitating the withdrawal or addition of dugs/solutions from or to the vial
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K072511 · printed Nov 6, 2026
Cite this page
510(k) Report. “K072511: Swabable Vial Adapter 13MM, Swabable Vial Adapter 20MM.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K072511
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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