510(k) · Cleared
ClearedToxiSeal Vial Adapter with External Balloon
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Epic Medical Pte., Ltd. · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Cleared on Jan 11, 2024 as substantially equivalent to K123213 (Becton, Dickinson & CO, 2013) after a 472-day review. Its family tree reaches back 7 generations to 1988. 2 later devices descend from it.
- Decided
- Jan 11, 2024
- Review
- 472 days
- Class
- Class II
- Product code
- ONB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K883614 (1988). 13 ancestors in all. 2 later devices descend from it, 1 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 deviceK222929 ToxiSeal Vial Adapter with External BalloonEpic Medical Pte., Ltd. · 2024
- Descendant · cites it directly · 1 of its ownK241476 ToxiSeal™ Vial Adaptor with External Flip BalloonEpic Medical Pte., Ltd. · 2024
- Descendant · 2 generations on · 0 of its ownK241823 ToxiSeal™ Vial AdaptorEpic Medical Pte., Ltd. · 2024
Most influential descendants
Showing 2 of 2 · See allView 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) | K222929 | ToxiSeal Vial Adapter with External Balloon | Epic Medical Pte., Ltd. | 2024 | — |
| +1 | K241476 | ToxiSeal™ Vial Adaptor with External Flip Balloon | Epic Medical Pte., Ltd. | 2024 | — |
| +2 | K241823 | ToxiSeal™ Vial Adaptor | Epic Medical Pte., Ltd. | 2024 | — |
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 |
|---|---|---|
| 2024 | 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 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 DeviceSummary page 5…21 CFR 880.5440 Regulatory Classification Class II Product Code ONB III. Predicate 510(K) Number K123213 Trade /Device Name BD PhaSeal® Closed System Drug Transfer Device Regulation Number 21 C… | 2013 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K241476 | ToxiSeal™ Vial Adaptor with External Flip Balloon | 2024 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 36 years and passes through 6 companies; a new generation was cleared every 4.7 years on median.
- 3 of the 13 ancestors have a recall of any class.
- Of its descendants, K241476 (Epic Medical Pte., Ltd., 2024) has gone furthest, with 1 descendant 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. 2024, 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 ToxiSealTM Vial Adaptor with External Balloon mechanically prohibits environmental contaminants from entering the system and the escape of drug or vapor concentrations from the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills. The device also prevents the introduction of microbial contaminations into the drug or fluid path for up to 168 hours (or 7 days) when used as intended.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K222929 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222929: ToxiSeal Vial Adapter with External Balloon.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222929
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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