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 24, 2007 as substantially equivalent to K980381 (Carmel Pharma Ab., 1998) after an 89-day review. Its family tree reaches back 3 generations to 1988. 11 later devices descend from it. It has been recalled once.
- Decided
- Sep 24, 2007
- Review
- 89 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. 11 later devices descend from it, 2 citing it directly.
- 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 deviceK071741 Tevadaptor, Closed Drug Reconstitution and Transfer SystemMigada Plant · 2007
- Descendant · cites it directly · 9 of its ownK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
- Descendant · 2 generations on · 3 of its ownK192866 Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK201422 Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK180489 TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2018
- Descendant · 3 generations on · 0 of its ownK253033 Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare, Ltd. · 2025
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015 · cites it directly9descendants
- K192866Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · 2 generations on3descendants
- K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021 · 2 generations on1descendant
- K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2018 · 2 generations on1descendant
- K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare, Ltd. · 2025 · 3 generations on0descendants
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) | K071741 | Tevadaptor, Closed Drug Reconstitution and Transfer System | Migada Plant | 2007 | — |
| +1 | K141448 | Tevadaptor Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2015 | — |
| +2 | K192866 | Chemfort CSTD | Simplivia Healthcare, Ltd. | 2020 | 1 |
| +2 | K201422 | Arisure Closed System Drug Transfer Device (CSTD) | Yukon Medical, LLC | 2021 | — |
| +2 | K180489 | TEVADAPTOR Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2018 | — |
| +3 | K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare, Ltd. | 2025 | — |
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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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.
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? (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 2…l® closed system for the preparation and administration of parenteral drugs, Carmel Pharna AB, S-402 28 Gottingen, Sweden, cleared under 510(k) no. K980381. Description of the device: The device comprises of the following components: -… | 1998 |
What descends from it? (11)
See all 112 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 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. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 19 years and passes through 4 companies; a new generation was cleared every 9.0 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K141448 (Teva Medical Ltd., Migada Plant, 2015) 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. 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 TEVADAPTOR M, Closed Drug Reconstitution and Transfer System is a closed system to be used by pharmacists or other healthcare professionals to prepare drugs, including cytotoxic drugs, for intravenous infusion or injection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K071741 · printed Nov 4, 2026
Cite this page
510(k) Report. “K071741: Tevadaptor, Closed Drug Reconstitution and Transfer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K071741
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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