510(k) · Cleared
Recalled · Class II · 2016Halo
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
J & J Solutions, Inc. D/B/A/ Corvida Medical · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Cleared on Jul 24, 2015 as substantially equivalent to K123213 (Becton, Dickinson & CO, 2013) and 2 other predicates after a 150-day review. Its family tree reaches back 8 generations to 1988. 1 later device descends from it. It has been recalled once.
- Decided
- Jul 24, 2015
- Review
- 150 days
- Class
- Class II
- Product code
- ONB
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 8 generations to K883614 (1988). 15 ancestors in all. 1 later device descends 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 deviceK150486 HaloJ & J Solutions, Inc. D/B/A/ Corvida Medical · 2015
- Descendant · cites it directly · 0 of its ownK180574 Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm…J & J Solutions, Inc. D/B/A/ Corvida Medical · 2018
Most influential descendants
Showing 1 of 1 · See all- K180574Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo…J & J Solutions, Inc. D/B/A/ Corvida Medical · 2018 · cites it directly0descendants
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) | K150486 | Halo | J & J Solutions, Inc. D/B/A/ Corvida Medical | 2015 | — |
| +1 | K180574 | Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck… | J & J Solutions, Inc. D/B/A/ Corvida Medical | 2018 | — |
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 |
| 2014 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 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? (3)
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…0 MANUFACTURER: Corvida Medical 2261 Crosspark Road, Suite 127 Coralville, Iowa 52241 PREDICATE DEVICES: Proprietary Name: BD PhaSeal CSTD (K123213, K130197, K140591) Common/Usual Name: Closed System Transfer Device Classification Name: Closed Antineoplas… | 2013 |
| * | K130197 | BD Phaseal Closed System Transfer Device - P55Summary page 5…ge 5 === MANUFACTURER: Corvida Medical 2261 Crosspark Road, Suite 127 Coralville, Iowa 52241 PREDICATE DEVICES: Proprietary Name: BD PhaSeal CSTD (K123213, K130197, K140591) Common/Usual Name: Closed System Transfer Device Classification Name: Closed Antineoplastic and H… | 2013 |
| * | K140591 | BD Phaseal Closed System Transfer Device - InjectorSummary page 5…MANUFACTURER: Corvida Medical 2261 Crosspark Road, Suite 127 Coralville, Iowa 52241 PREDICATE DEVICES: Proprietary Name: BD PhaSeal CSTD (K123213, K130197, K140591) Common/Usual Name: Closed System Transfer Device Classification Name: Closed Antineoplastic and Hazardous… | 2014 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180574 | Halo Closed Vial Adaptor (Multiple Models based on 13, 20 or 28mm Vial Neck Size), Halo… | 2018 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Nov 22, 2016 | Class II | Z-1003-2017 | Under Investigation by firm | Product malfunction: Needle does not retract. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 7 companies; a new generation was cleared every 2.4 years on median.
- 5 of the 15 ancestors have a recall of any class.
- Of its descendants, K180574 (J & J Solutions, Inc. D/B/A/ Corvida Medical, 2018) has gone furthest, with 0 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. 2015, 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 Halo system is an airtight and leak proof closed system drug transfer device (CSTD) that 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. The Halo system also prevents microbial ingress for up to 168 hours.
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/K150486 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150486: Halo.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150486
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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