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 May 16, 2017 as substantially equivalent to K141448 (Teva Medical Ltd., Migada Plant, 2015) after a 71-day review. Its family tree reaches back 9 generations to 1988. 3 of the 36 devices in its family, counting itself, have a Class I recall.
- Decided
- May 16, 2017
- Review
- 71 days
- Class
- Class II
- Product code
- ONB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to K883614 (1988). 35 ancestors in all. No later device cites it as a predicate yet. 3 of the 36 devices in this family, counting this one, have a Class I recall.
- Root · 9 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 5 generations between
- 3 generations backK123213 BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO · 2013 · Recalled
- 2 generations backK130197 BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company · 2013 · Recalled
- 1 generation backK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
- This deviceK170680 TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2017
Show all 9 generations
- Root · 9 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 8 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 7 generations backK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- 6 generations backK023747 PhasealCarmel Pharma Ab. · 2002
- 5 generations backK110023 Infusion Adapter C100Carmel Pharma Ab. · 2011
- 4 generations backK120384 Protector, Injector, ConnectorBd Medical-Medical Surgical Systems · 2012
- 3 generations backK123213 BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO · 2013 · Recalled
- 2 generations backK130197 BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company · 2013 · Recalled
- 1 generation backK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
- This deviceK170680 TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2017
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −8 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −7 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| −6 | K023747 | Phaseal | Carmel Pharma Ab. | 2002 | — |
| −5 | K110023 | Infusion Adapter C100 | Carmel Pharma Ab. | 2011 | — |
| −4 | K120384 | Protector, Injector, Connector | Bd Medical-Medical Surgical Systems | 2012 | — |
| −3 | K123213 | BD Phaseal Closed System Transfer Device | Becton, Dickinson & CO | 2013 | 2 |
| −2 | K130197 | BD Phaseal Closed System Transfer Device - P55 | Becton, Dickinson and Company | 2013 | 1 |
| −1 | K141448 | Tevadaptor Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2015 | — |
| 0 (this device) | K170680 | TEVADAPTOR Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2017 | — |
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 |
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? (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 |
|---|---|---|---|
| * | K141448 | Tevadaptor Closed Drug Reconstitution and Transfer SystemSummary page 5…ution and Transfer System is: Predicate Device Name: TEVADAPTOR® Closed Drug Reconstitution and Transfer System 510(k) Sponsor: Teva Medical 510(k) Number: K141448 Clearance Date: 23 January 2015 FDA Product Code: ONB Regulation Name: Intravascular administration set Regulation… | 2015 |
| † | K071741 | Tevadaptor, Closed Drug Reconstitution and Transfer System | 2007 |
What descends from it?
No later submission names this one as a predicate yet.
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 · 2 generations back · ◆ in the 2013 ancestors bar of FIG. 12 Class I recalls
- K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · 3 generations back · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
- K964435Primary IV SetIcu Medical, Inc. · 1997 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 15 Class I recalls
What does this lineage say?
- The line of descent spans 29 years and passes through 7 companies; a new generation was cleared every 1.9 years on median.
- 12 of the 35 ancestors have a recall of any class; 3 have a Class I recall.
- 3 other devices also cite its predicate K141448.
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. 2017, 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/K170680 · printed Nov 5, 2026
Cite this page
510(k) Report. “K170680: 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/K170680
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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