510(k) · Cleared
Recalled · 2008Tevadaptor Closed Drug Reconstitution and Transfer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Migada Plant · LHI Set, I.V. Fluid Transfer
Cleared on Sep 1, 2005 as substantially equivalent to K980381 (Carmel Pharma Ab., 1998) after a 71-day review. Its family tree reaches back 3 generations to 1988. 2 of the 19 devices in its family, counting itself, have a Class I recall. 13 later devices descend from it. It has been recalled once.
- Decided
- Sep 1, 2005
- Review
- 71 days
- Class
- Class II
- Product code
- LHI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K883614 (1988). 5 ancestors in all. 13 later devices descend from it, 2 citing it directly. 2 of the 19 devices in this family, counting this one, have a Class I recall.
- Root · 3 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 2 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 1 generation backK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- This deviceK051669 Tevadaptor Closed Drug Reconstitution and Transfer SystemMigada Plant · 2005
- Descendant · cites it directly · 9 of its ownK083152 Equashield SystemPlastmed, Ltd. · 2009
- Descendant · 2 generations on · 8 of its ownK091389 Equalshield Luer Lock Connector PairPlastmed, Ltd. · 2009
- Descendant · 2 generations on · 7 of its ownK101940 Equashield System Protective PlusEquashield Medical, Ltd. · 2010
- Descendant · 3 generations on · 6 of its ownK132899 Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014
- Descendant · 4 generations on · 5 of its ownK170706 Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 13 · See all- K083152Equashield SystemPlastmed, Ltd. · 2009 · cites it directly9descendants
- K091389Equalshield Luer Lock Connector PairPlastmed, Ltd. · 2009 · 2 generations on8descendants
- K101940Equashield System Protective PlusEquashield Medical, Ltd. · 2010 · 2 generations on7descendants
- K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014 · 3 generations on6descendants
- K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −2 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −1 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| 0 (this device) | K051669 | Tevadaptor Closed Drug Reconstitution and Transfer System | Migada Plant | 2005 | — |
| +1 | K083152 | Equashield System | Plastmed, Ltd. | 2009 | — |
| +2 | K091389 | Equalshield Luer Lock Connector Pair | Plastmed, Ltd. | 2009 | — |
| +2 | K101940 | Equashield System Protective Plus | Equashield Medical, Ltd. | 2010 | — |
| +3 | K132899 | Equashield Closed System Drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2014 | — |
| +4 | K170706 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 1 |
| 2009 | 2 | 0 |
| 2010 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 2 | 1 |
| 2022 | 1 | 0 |
| 2023 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 2 | 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 |
|---|---|---|---|
| * | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional Administration…Summary page 4…ed system for the preparation and administration of parenteral drugs. Carmel Pharma AB. S-402 28 Gottingen, Sweden, cleared under 5 10(k) no. K980381. Description of the device: The device comprises of the following components: - Vial… | 1998 |
What descends from it? (13)
See all 132 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Dec 18, 2008 | Not classified | Z-1244-2009 | Component design/selection | Syringe adaptor is disintegrating when attached to the end of the syringe. |
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 17 years and passes through 4 companies; a new generation was cleared every 7.5 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K083152 (Plastmed, Ltd., 2009) has gone furthest, with 9 descendants of its own.
- 6 other devices also cite its predicate K980381.
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?
The TEVADAPTOR", Drug Reconstitution and Transfer System is a contained system
to be used by pharmacists or other healthcare professionals to prepare drugs, including
cytotoxic drugs, for intravenous infusion or injection.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K051669 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051669: Tevadaptor Closed Drug Reconstitution and Transfer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051669
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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