510(k) · Cleared
ClearedTevadaptor Closed Drug Reconstitution and Transfer System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teva Medical Ltd., Migada Plant · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Cleared on Jan 23, 2015 as substantially equivalent to K071741 (Migada Plant, 2007) and 3 other predicates after a 235-day review. Its family tree reaches back 8 generations to 1988. 3 of the 44 devices in its family, counting itself, have a Class I recall. 9 later devices descend from it.
- Decided
- Jan 23, 2015
- Review
- 235 days
- Class
- Class II
- Product code
- ONB
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 8 generations to K883614 (1988). 34 ancestors in all. 9 later devices descend from it, 4 citing it directly. 3 of the 44 devices in this family, counting this one, have a Class I recall.
- Root · 8 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 7 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 6 generations backK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- 5 generations backK023747 PhasealCarmel Pharma Ab. · 2002
- 4 generations backK110023 Infusion Adapter C100Carmel Pharma Ab. · 2011
- 3 generations backK120384 Protector, Injector, ConnectorBd Medical-Medical Surgical Systems · 2012
- 2 generations backK123213 BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO · 2013 · Recalled
- 1 generation backK130197 BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company · 2013 · Recalled
- This deviceK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
- Descendant · cites it directly · 3 of its ownK192866 Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · Recalled
- Descendant · cites it directly · 1 of its ownK201422 Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021
- Descendant · cites it directly · 1 of its ownK180489 TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2018
- Descendant · 2 generations on · 0 of its ownK253033 Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare, Ltd. · 2025
- Descendant · 2 generations on · 0 of its ownK251411 Chemfort Female Luer Lock AdaptorSimplivia Healthcare, Ltd. · 2025
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
Most influential descendants
Showing 5 of 9 · See all- K192866Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · cites it directly3descendants
- K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021 · cites it directly1descendant
- K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2018 · cites it directly1descendant
- K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare, Ltd. · 2025 · 2 generations on0descendants
- K251411Chemfort Female Luer Lock AdaptorSimplivia Healthcare, Ltd. · 2025 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −7 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −6 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| −5 | K023747 | Phaseal | Carmel Pharma Ab. | 2002 | — |
| −4 | K110023 | Infusion Adapter C100 | Carmel Pharma Ab. | 2011 | — |
| −3 | K120384 | Protector, Injector, Connector | Bd Medical-Medical Surgical Systems | 2012 | — |
| −2 | K123213 | BD Phaseal Closed System Transfer Device | Becton, Dickinson & CO | 2013 | 2 |
| −1 | K130197 | BD Phaseal Closed System Transfer Device - P55 | Becton, Dickinson and Company | 2013 | 1 |
| 0 (this device) | K141448 | Tevadaptor Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2015 | — |
| +1 | K192866 | Chemfort CSTD | Simplivia Healthcare, Ltd. | 2020 | 1 |
| +1 | K201422 | Arisure Closed System Drug Transfer Device (CSTD) | Yukon Medical, LLC | 2021 | — |
| +1 | K180489 | TEVADAPTOR Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2018 | — |
| +2 | K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare, Ltd. | 2025 | — |
| +2 | K251411 | Chemfort Female Luer Lock Adaptor | Simplivia Healthcare, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 1 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 4 | 0 |
| 2008 | 2 | 1 |
| 2009 | 3 | 0 |
| 2013 | 1 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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.
3 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 ONB device
- #1 K240171 ProSeal™ Injector Plus (Model no. 421050)score 18.2 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K071741 | Tevadaptor, Closed Drug Reconstitution and Transfer SystemSummary page 5…nd Transfer System are, in the main, identical, and processed in an identical manner, to those used in the predicate device TEVADAPTOR® System that was the subject of K071741, cleared by FDA on 24 September 2007. For any materials not previously used, technical and safety information has been asse… | 2007 |
| * | K123213 | BD Phaseal Closed System Transfer DeviceSummary page 7…e Device 2 (PD 2): BD PhaSeal Closed System Drug Transfer Device 510(k) Sponsor: Becton Dickinson & Co, New Jersey, USA 510(k) Number: K123213 and K130197 Clearance Date: 09 January 2013 and 27 February 2013 FDA Product Code: ONB Classific… | 2013 |
| * | K130197 | BD Phaseal Closed System Transfer Device - P55Summary page 7…PD 2): BD PhaSeal Closed System Drug Transfer Device 510(k) Sponsor: Becton Dickinson & Co, New Jersey, USA 510(k) Number: K123213 and K130197 Clearance Date: 09 January 2013 and 27 February 2013 FDA Product Code: ONB Classification Name:… | 2013 |
| * | K131549 | Chemolock, Chemolock PortSummary page 7…Predicate Device 3 (PD 3): ChemoLock Closed System Drug Transfer Device 510(k) Sponsor: ICU Medical Inc., Utah, USA 510(k) Number: K131549 Clearance Date: 26 July 2013 FDA Product Code: ONB Classification Name: Closed antineopl… | 2013 |
What descends from it? (9)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (3 Class I)
No FDA recall names this device.
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.
- K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · Direct predicate · ◆ in the 2013 ancestors bar of FIG. 12 Class I recalls
- K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · 2 generations back · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
- K964435Primary IV SetIcu Medical, Inc. · 1997 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 34 ancestors have a recall of any class; 3 have a Class I recall.
- Of its descendants, K192866 (Simplivia Healthcare, Ltd., 2020) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K071741.
How does its category compare?
All ONB devicesONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · ONB
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · ONB
60in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONB
38in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · ONB
934in 2025
MAUDE reports naming product code ONB, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 1 |
| 2013 | 3 | 58 | 0 | 2 |
| 2014 | 2 | — | 0 | 3 |
| 2015 | 3 | 235 | 0 | 4 |
| 2016 | 0 | — | 1 | 13 |
| 2017 | 2 | — | 0 | 66 |
| 2018 | 6 | 249 | 0 | 228 |
| 2019 | 1 | — | 1 (1) | 464 |
| 2020 | 3 | 213 | 4 | 442 |
| 2021 | 3 | 277 | 0 | 548 |
| 2022 | 1 | — | 1 | 448 |
| 2023 | 3 | 175 | 1 | 456 |
| 2024 | 8 | 102 | 1 | 686 |
| 2025 | 6 | 60 | 38 | 934 |
| 2026 | 0 | — | 3 | — |
What is it indicated for?
TEVADAPTOR is a Closed System Drug Transfer Device (CSTD) that mechanically prohibits the release of the drug in vapor, aerosol or liquid form during preparation and administration, and prevents the introduction of microbial and airborne contaminants into the drug or fluid path, allowing the system to minimize exposure of individuals, healthcare personnel, and the environment to hazardous drugs.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K141448 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141448: Tevadaptor Closed Drug Reconstitution and Transfer System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K141448
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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