510(k) · Cleared
ClearedEquashield Closed System Drug Transfer Device (CSTD)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Equashield Medical, Ltd. · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Cleared on May 13, 2014 as substantially equivalent to K101940 (Equashield Medical, Ltd., 2010) and 1 other predicate after a 239-day review. Its family tree reaches back 8 generations to 1988. 6 later devices descend from it.
- Decided
- May 13, 2014
- Review
- 239 days
- Class
- Class II
- Product code
- ONB
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 8 generations to K883614 (1988). 23 ancestors in all. 6 later devices descend from it, 1 citing it directly.
- 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 deviceK132899 Equashield Closed System Drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2014
- Descendant · cites it directly · 5 of its ownK170706 Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017
- Descendant · 2 generations on · 3 of its ownK201460 Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd. · 2022
- Descendant · 3 generations on · 2 of its ownK241988 ProSeal™ Closed System Bag AccessEpic Medical Pte., Ltd. · 2024
- Descendant · 4 generations on · 0 of its ownK251340 ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd. · 2025
- Descendant · 4 generations on · 0 of its ownK243976 ZeroClear™ Bag Access (423100)Epic Medical Pte., Ltd. · 2025
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K170706Equashield Closed System drug Transfer Device (CSTD)Equashield Medical, Ltd. · 2017 · cites it directly5descendants
- K201460Closed System Transfer DeviceShinva Ande Healthcare Apparatus Co., Ltd. · 2022 · 2 generations on3descendants
- K241988ProSeal™ Closed System Bag AccessEpic Medical Pte., Ltd. · 2024 · 3 generations on2descendants
- K251340ProSeal™ Bag Spike with Additive Port (423370ST, 423370)Epic Medical Pte., Ltd. · 2025 · 4 generations on0descendants
- K243976ZeroClear™ Bag Access (423100)Epic Medical Pte., Ltd. · 2025 · 4 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) | K132899 | Equashield Closed System Drug Transfer Device (CSTD) | Equashield Medical, Ltd. | 2014 | — |
| +1 | 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 | — |
| +3 | K241988 | ProSeal™ Closed System Bag Access | Epic Medical Pte., Ltd. | 2024 | — |
| +4 | K251340 | ProSeal™ Bag Spike with Additive Port (423370ST, 423370) | Epic Medical Pte., Ltd. | 2025 | — |
| +4 | K243976 | ZeroClear™ Bag Access (423100) | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2022 | 1 | 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.
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? (2)
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 |
|---|---|---|---|
| * | K101940 | Equashield System Protective PlusSummary page 1…General Hospital Product Code: ONB Device Class: Class 11 Regulation: 21 C.F.R. §880.5440 Predicate Device Information K 10 1940 Equashield Closed System, cleared November 19, 2010 K 130197 PhaSeal Closed System, cleared February 27, 2013… | 2010 |
| * | K130197 | BD Phaseal Closed System Transfer Device - P55Summary page 1…ass: Class 11 Regulation: 21 C.F.R. §880.5440 Predicate Device Information K 10 1940 Equashield Closed System, cleared November 19, 2010 K 130197 PhaSeal Closed System, cleared February 27, 2013… | 2013 |
What descends from it? (6)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K170706 | Equashield Closed System drug Transfer Device (CSTD) | 2017 | 5 |
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 26 years and passes through 7 companies; a new generation was cleared every 1.4 years on median.
- 8 of the 23 ancestors have a recall of any class.
- Of its descendants, K170706 (Equashield Medical, Ltd., 2017) has gone furthest, with 5 descendants of its own.
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. 2014, 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?
Closed System drug Transfer Device (CSTD) for preparation, reconstitution, compounding and administration of drugs, including antineoplastic and hazardous drugs. This closed system mechanically prohibits the transfer of environmental contaminants into the system and the escape of drug or vapor concentrations outside the system, thereby minimizing individual and environmental exposure to drug vapor, aerosols, and spills and also prevents microbial ingress.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K132899 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132899: Equashield Closed System Drug Transfer Device (CSTD).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132899
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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