510(k) · Cleared
Recalled · Class II · 2025BD Phaseal Closed System Transfer Device - P55
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Becton, Dickinson and Company · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Cleared on Feb 27, 2013 as substantially equivalent to K123213 (Becton, Dickinson & CO, 2013) after a 30-day review. Its family tree reaches back 7 generations to 1988. 19 later devices descend from it. It has been recalled once.
- Decided
- Feb 27, 2013
- Review
- 30 days
- Class
- Class II
- Product code
- ONB
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K883614 (1988). 13 ancestors in all. 19 later devices descend from it, 3 citing it directly.
- Root · 7 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 6 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 5 generations backK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- 4 generations backK023747 PhasealCarmel Pharma Ab. · 2002
- 3 generations backK110023 Infusion Adapter C100Carmel Pharma Ab. · 2011
- 2 generations backK120384 Protector, Injector, ConnectorBd Medical-Medical Surgical Systems · 2012
- 1 generation backK123213 BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO · 2013 · Recalled
- This deviceK130197 BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company · 2013
- Descendant · cites it directly · 9 of its ownK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
- Descendant · cites it directly · 6 of its ownK132899 Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014
- Descendant · 2 generations on · 5 of its ownK170706 Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017
- Descendant · 3 generations on · 3 of its ownK201460 Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd. · 2022
- Descendant · 2 generations on · 3 of its ownK192866 Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · Recalled
Showing 5 of 19 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 19 · See all- K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015 · cites it directly9descendants
- K132899Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014 · cites it directly6descendants
- K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017 · 2 generations on5descendants
- K201460Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd. · 2022 · 3 generations on3descendants
- K192866Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · 2 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −6 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −5 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| −4 | K023747 | Phaseal | Carmel Pharma Ab. | 2002 | — |
| −3 | K110023 | Infusion Adapter C100 | Carmel Pharma Ab. | 2011 | — |
| −2 | K120384 | Protector, Injector, Connector | Bd Medical-Medical Surgical Systems | 2012 | — |
| −1 | K123213 | BD Phaseal Closed System Transfer Device | Becton, Dickinson & CO | 2013 | 2 |
| 0 (this device) | K130197 | BD Phaseal Closed System Transfer Device - P55 | Becton, Dickinson and Company | 2013 | — |
| +1 | K141448 | Tevadaptor Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2015 | — |
| +1 | K132899 | Equashield Closed System Drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2014 | — |
| +2 | K170706 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2017 | — |
| +3 | K201460 | Closed System Transfer Device | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022 | — |
| +2 | K192866 | Chemfort CSTD | Simplivia Healthcare, Ltd. | 2020 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 1 | 0 |
| 2000 | 1 | 0 |
| 2006 | 1 | 0 |
| 2009 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 2 | 0 |
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 0 |
| 2025 | 4 | 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 ONB? 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 |
|---|---|---|---|
| * | K123213 | BD Phaseal Closed System Transfer Device | 2013 |
What descends from it? (19)
See all 193 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 |
|---|---|---|---|---|
| Jun 16, 2025 | Class II | Z-2453-2025 | Error in labeling | Closed system drug transfer devices were shipped to the U.S. market without a U.S. version of the instructions for use, which could be an issue if a healthcare professional is prompted to review it. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 6 companies; a new generation was cleared every 1.4 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K141448 (Teva Medical Ltd., Migada Plant, 2015) has gone furthest, with 9 descendants of its own.
- 8 other devices also cite its predicate K123213.
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. 2013, 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?
The PhaSeal system is an airtight and leakproof closed system drug transfer device
(CSTD) that mechanically prohibits the transfer of environmental contaminants into the
system and the escape of drug or vapor contractions outside the system thereby
minimizing individual and environmental exposure to drug vapor, aerosols and spills.
The PhaSeal system also prevents microbial ingress.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K130197 · printed Nov 4, 2026
Cite this page
510(k) Report. “K130197: BD Phaseal Closed System Transfer Device - P55.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K130197
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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