510(k) · Cleared
Recalled · Class II · 2017VIAL2BAG Direct Connect
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 Jun 12, 2014 as substantially equivalent to K072759 (Medimop Medical Projects, Ltd., 2007) and 1 other predicate after an 80-day review. Its family tree reaches back 5 generations to 1988. 2 of the 14 devices in its family, counting itself, have a Class I recall. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 12, 2014
- Review
- 80 days
- Class
- Class II
- Product code
- LHI
- Recalls
- 1
- Predicates
- 2
Its longest line of descent runs back 5 generations to K883614 (1988). 12 ancestors in all, the oldest K790472 (1979). 1 later device descends from it, 1 citing it directly. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 5 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 4 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 3 generations backK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- 2 generations backK051669 Tevadaptor Closed Drug Reconstitution and Transfer SystemMigada Plant · 2005 · Recalled
- 1 generation backK072759 VIAL2BAGMedimop Medical Projects, Ltd. · 2007 · Recalled (Class I)
- This deviceK140730 VIAL2BAG Direct ConnectMedimop Medical Projects, Ltd. · 2014
- Descendant · cites it directly · 0 of its ownK170095 Vial2Bag Direct ConnectMedimop Medical Project, Ltd. · 2017 · Recalled (Class I)
Class I recalls in this family
Most influential descendants
Showing 1 of 1 · See all- K170095Vial2Bag Direct ConnectMedimop Medical Project, Ltd. · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −4 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −3 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| −2 | K051669 | Tevadaptor Closed Drug Reconstitution and Transfer System | Migada Plant | 2005 | 1 |
| −1 | K072759 | VIAL2BAG | Medimop Medical Projects, Ltd. | 2007 | Class I |
| 0 (this device) | K140730 | VIAL2BAG Direct Connect | Medimop Medical Projects, Ltd. | 2014 | — |
| +1 | K170095 | Vial2Bag Direct Connect | Medimop Medical Project, Ltd. | 2017 | Class I |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1979 | 1 | 0 |
| 1994 | 2 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K072759 | VIAL2BAGSummary page 2…entification: General Hospital Panel Predicate Devices: Vial2Bag from Medimop Medical Projects, Ltd, cleared by 510O(k) number K072759 Mixject Dispensing Pin (Vial Adapter) from Medimop Medical Projects,… | 2007 |
| * | K001293 | Modification to Mixject Dispensing Pin/with Detachable Vial Holder/with Detachable Vial…Summary page 2…er K072759 Mixject Dispensing Pin (Vial Adapter) from Medimop Medical Projects, Ltd cleared by 510O(k) number K001293 Device Description: TM TM The proposed device, Vial2B~… | 2000 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170095 | Vial2Bag Direct Connect Class I | 2017 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 6, 2017 | Class II | Z-0972-2018 | Process control | Medimop is recalling certain lots of this product Vial2Bag DC due to the potential of the IV Port separating from the Via12Bag DC body during the drug reconstitution I IV Set attachment process. |
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 26 years and passes through 5 companies; a new generation was cleared every 6.5 years on median.
- 3 of the 12 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K170095 (Medimop Medical Project, Ltd., 2017) has gone furthest, with 0 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. 2014, 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 Vial2BagTM Direct Connect is indicated to serve as a connecting part between the IV bag and an external IV line. The integrated vial adapter makes it possible to reconstitute and admix drugs from a vial into the infusion solution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K140730 · printed Nov 5, 2026
Cite this page
510(k) Report. “K140730: VIAL2BAG Direct Connect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K140730
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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