510(k) · Cleared
ClearedProSeal™ Bag Spike with Additive Port (423370ST, 423370)
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 May 29, 2025 as substantially equivalent to K241988 (Epic Medical Pte., Ltd., 2024) after a 29-day review. Its family tree reaches back 12 generations to 1988.
- Decided
- May 29, 2025
- Review
- 29 days
- Class
- Class II
- Product code
- ONB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 12 generations to K883614 (1988). 28 ancestors in all. No later device cites it as a predicate yet.
- Root · 12 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 8 generations between
- 3 generations backK170706 Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017
- 2 generations backK201460 Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd. · 2022
- 1 generation backK241988 ProSeal™ Closed System Bag AccessEpic Medical Pte., Ltd. · 2024
- This deviceK251340 ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd. · 2025
Show all 12 generations
- Root · 12 generations backK883614 Cytoguard (R)Survival Technology, Inc. · 1988
- 11 generations backK972527 Phaseal, System for Sealed Handling of Chemotherapeutic AgentsQuality System Consulting · 1997
- 10 generations backK980381 Phaseal, Closed System Forhandling of Parenteral Drugs, Additional…Carmel Pharma Ab. · 1998
- 9 generations backK023747 PhasealCarmel Pharma Ab. · 2002
- 8 generations backK110023 Infusion Adapter C100Carmel Pharma Ab. · 2011
- 7 generations backK120384 Protector, Injector, ConnectorBd Medical-Medical Surgical Systems · 2012
- 6 generations backK123213 BD Phaseal Closed System Transfer DeviceBecton, Dickinson & CO · 2013 · Recalled
- 5 generations backK130197 BD Phaseal Closed System Transfer Device - P55Becton, Dickinson and Company · 2013 · Recalled
- 4 generations backK132899 Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014
- 3 generations backK170706 Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017
- 2 generations backK201460 Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd. · 2022
- 1 generation backK241988 ProSeal™ Closed System Bag AccessEpic Medical Pte., Ltd. · 2024
- This deviceK251340 ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd. · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K883614 | Cytoguard (R) | Survival Technology, Inc. | 1988 | — |
| −11 | K972527 | Phaseal, System for Sealed Handling of Chemotherapeutic Agents | Quality System Consulting | 1997 | — |
| −10 | K980381 | Phaseal, Closed System Forhandling of Parenteral Drugs, Additional… | Carmel Pharma Ab. | 1998 | — |
| −9 | K023747 | Phaseal | Carmel Pharma Ab. | 2002 | — |
| −8 | K110023 | Infusion Adapter C100 | Carmel Pharma Ab. | 2011 | — |
| −7 | K120384 | Protector, Injector, Connector | Bd Medical-Medical Surgical Systems | 2012 | — |
| −6 | K123213 | BD Phaseal Closed System Transfer Device | Becton, Dickinson & CO | 2013 | 2 |
| −5 | K130197 | BD Phaseal Closed System Transfer Device - P55 | Becton, Dickinson and Company | 2013 | 1 |
| −4 | K132899 | Equashield Closed System Drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2014 | — |
| −3 | K170706 | Equashield Closed System drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2017 | — |
| −2 | K201460 | Closed System Transfer Device | Shinva Ande Healthcare Apparatus Co., Ltd. | 2022 | — |
| −1 | K241988 | ProSeal™ Closed System Bag Access | Epic Medical Pte., Ltd. | 2024 | — |
| 0 (this device) | K251340 | ProSeal™ Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte., Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 1995 | 2 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 1 | 0 |
| 2009 | 4 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 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 |
|---|---|---|---|
| * | K241988 | ProSeal™ Closed System Bag AccessSummary page 5…ation Name: 21 CFR 880.5440 Regulatory Class: Class: II Product Code: ONB III. Predicate 510(k) Number: K241988 Trade/ Device Name: ProSeal™ Closed System Bag Access Closed Antineoplastic and Haza… | 2024 |
| † | K240171 | ProSeal™ Injector Plus (Model no. 421050) | 2024 |
| † | K230343 | ProSeal™ Closed System Administration Set | 2023 |
| † | K223674 | eZSURE™ Empty Fluid Container (models 426030, 426040, 426110) | 2023 |
| † | K222929 | ToxiSeal Vial Adapter with External Balloon | 2024 |
| † | K240433 | ProSeal™ Injection Site Extended Male Luer Lock (422140) | 2024 |
| † | K151650 | SMARTez elastomeric infusion pump | 2016 |
What descends from it?
No later submission names this one as a predicate yet.
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 37 years and passes through 9 companies; a new generation was cleared every 1.9 years on median.
- 8 of the 28 ancestors have a recall of any class.
- 1 other device also cites its predicate K241988.
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. 2025, 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 ProSeal™ CSTD 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 ProSeal™ system also prevents the introduction of microbial contaminations into the drug or fluid path for up to 7 days when used as intended.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K251340 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251340: ProSeal™ Bag Spike with Additive Port (423370ST, 423370).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251340
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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