510(k) · Cleared
Recalled · Class I · 2018Vial2Bag Direct Connect
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Medimop Medical Project, Ltd. · LHI Set, I.V. Fluid Transfer
Cleared on Mar 8, 2017 as substantially equivalent to K140730 (Medimop Medical Projects, Ltd., 2014) after a 56-day review. Its family tree reaches back 6 generations to 1988. 2 of the 14 devices in its family, counting itself, have a Class I recall. It has been recalled 3 times, including 2 Class I recalls.
- Decided
- Mar 8, 2017
- Review
- 56 days
- Class
- Class II
- Product code
- LHI
- Recalls
- 3 (2 Class I)
- Predicates
- 1
Its longest line of descent runs back 6 generations to K883614 (1988). 13 ancestors in all, the oldest K790472 (1979). No later device cites it as a predicate yet. 2 of the 14 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 5 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 4 generations backK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- 3 generations backK051669 Tevadaptor Closed Drug Reconstitution and Transfer SystemMigada Plant · 2005 · Recalled
- 2 generations backK072759 VIAL2BAGMedimop Medical Projects, Ltd. · 2007 · Recalled (Class I)
- 1 generation backK140730 VIAL2BAG Direct ConnectMedimop Medical Projects, Ltd. · 2014 · Recalled
- This deviceK170095 Vial2Bag Direct ConnectMedimop Medical Project, Ltd. · 2017
Class I recalls in this family
- K072759 VIAL2BAG2 generations back · 2007
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −5 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −4 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| −3 | K051669 | Tevadaptor Closed Drug Reconstitution and Transfer System | Migada Plant | 2005 | 1 |
| −2 | K072759 | VIAL2BAG | Medimop Medical Projects, Ltd. | 2007 | Class I |
| −1 | K140730 | VIAL2BAG Direct Connect | Medimop Medical Projects, Ltd. | 2014 | 1 |
| 0 (this device) | K170095 | Vial2Bag Direct Connect | Medimop Medical Project, Ltd. | 2017 | — |
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 |
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 |
|---|---|---|---|
| * | K140730 | VIAL2BAG Direct ConnectSummary page 4…Class: II Panel Identification: General Hospital Panel Predicate Devices: Vial2Bag Direct Connect, cleared by 510(k) K140730 Device Description The proposed device, Vial2Bag Direct Connect, is intended for use in healthcare facilities or in home environm… | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 26, 2018 | Class I | Z-0767-2019 | Device Design | Adverse events have been reported with the use of oxytocin in conjunction with the product in pregnant women. There is a possibility that the device may cause inadequate admixing of drug with the solution in the IV bag. This could lead to… |
| Dec 26, 2018 | Class I | Z-0769-2019 | Device Design | Adverse events have been reported with the use of oxytocin in conjunction with the 13mm Vial2Bag DC in pregnant women. Vial2Bag DC 20mm is recalled due to similarities with 13mm Vial2Bag DC. |
| 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.
- K072759VIAL2BAGMedimop Medical Projects, Ltd. · 2007 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 29 years and passes through 6 companies; a new generation was cleared every 6.5 years on median.
- 4 of the 13 ancestors have a recall of any class; 1 has a Class I recall.
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. 2017, 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 Vial2Bag™ 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/K170095 · printed Nov 6, 2026
Cite this page
510(k) Report. “K170095: Vial2Bag Direct Connect.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K170095
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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