510(k) · Cleared
ClearedVial Connector 13MM Closed Collar
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 Jul 31, 2013 as substantially equivalent to K963583 (Medimop Medical Projects, Ltd., 1996) and 1 other predicate after a 29-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Jul 31, 2013
- Review
- 29 days
- Class
- Class II
- Product code
- LHI
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K963583 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK963583 Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable…Medimop Medical Projects, Ltd. · 1996
- This deviceK132040 Vial Connector 13MM Closed CollarMedimop Medical Projects, Ltd. · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K963583 | Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder… | Medimop Medical Projects, Ltd. | 1996 | — |
| 0 (this device) | K132040 | Vial Connector 13MM Closed Collar | Medimop Medical Projects, Ltd. | 2013 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 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 |
|---|---|---|---|
| * | K963583 | Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial Holder and…Summary page 1…General Hospital Panel Predicate Devices: Mixject Dispensing Pin from Medimop Medical Projects, Ltd, cleared by 510O(k) number K963 583 and KOO 1293 25 June 2013 Page 38 of 207… | 1996 |
| * | K001293 | Modification to Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial…Summary page 2…concerns regarding safety and effectiveness and may therefore be considered substantially equivalent to the predicate device, Mixject Dispensing Pin, 510(k) K963583 and K00 1293. 25 June 2013 Page 39 of 207 2 DEPA… | 2000 |
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?
- None of the 2 ancestors has a recall.
- 5 other devices also cite its predicate K963583.
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. 2013, 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 proposed device is indicated for the transfer and mixing of drugs contained in a vial.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132040 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132040: Vial Connector 13MM Closed Collar.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K132040
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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