510(k) · Cleared
Recalled · Class I · 2026Chemolock, Chemolock Port
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · ONB Closed Antineoplastic And Hazardous Drug Reconstitution And Transfer System
Cleared on Jul 26, 2013 as substantially equivalent to K123213 (Becton, Dickinson & CO, 2013) and 2 other predicates after a 58-day review. Its family tree reaches back 7 generations to 1988. 3 of the 42 devices in its family, counting itself, have a Class I recall. 10 later devices descend from it. It has been recalled 60 times, including 2 Class I recalls.
- Decided
- Jul 26, 2013
- Review
- 58 days
- Class
- Class II
- Product code
- ONB
- Recalls
- 60 (2 Class I)
- Predicates
- 3
Its longest line of descent runs back 7 generations to K883614 (1988). 31 ancestors in all. 10 later devices descend from it, 1 citing it directly. 3 of the 42 devices in this family, counting this one, have a Class I recall.
- 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 deviceK131549 Chemolock, Chemolock PortIcu Medical, Inc. · 2013
- Descendant · cites it directly · 9 of its ownK141448 Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015
- Descendant · 2 generations on · 3 of its ownK192866 Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · Recalled
- Descendant · 2 generations on · 1 of its ownK201422 Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021
- Descendant · 2 generations on · 1 of its ownK180489 TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2018
- Descendant · 3 generations on · 0 of its ownK253033 Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare, Ltd. · 2025
Showing 5 of 10 descendants. See all descendants
Descendants cleared per year
2015high 2 (2021) · low 0 (2016)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 10 · See all- K141448Tevadaptor Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2015 · cites it directly9descendants
- K192866Chemfort CSTDSimplivia Healthcare, Ltd. · 2020 · 2 generations on3descendants
- K201422Arisure Closed System Drug Transfer Device (CSTD)Yukon Medical, LLC · 2021 · 2 generations on1descendant
- K180489TEVADAPTOR Closed Drug Reconstitution and Transfer SystemTeva Medical Ltd., Migada Plant · 2018 · 2 generations on1descendant
- K253033Chemfort® 28-day 20 mm Vial Adaptor and 13 mm ConvertorSimplivia Healthcare, Ltd. · 2025 · 3 generations on0descendants
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) | K131549 | Chemolock, Chemolock Port | Icu Medical, Inc. | 2013 | — |
| +1 | K141448 | Tevadaptor Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2015 | — |
| +2 | K192866 | Chemfort CSTD | Simplivia Healthcare, Ltd. | 2020 | 1 |
| +2 | K201422 | Arisure Closed System Drug Transfer Device (CSTD) | Yukon Medical, LLC | 2021 | — |
| +2 | K180489 | TEVADAPTOR Closed Drug Reconstitution and Transfer System | Teva Medical Ltd., Migada Plant | 2018 | — |
| +3 | K253033 | Chemfort® 28-day 20 mm Vial Adaptor and 13 mm Convertor | Simplivia Healthcare, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 4 | 0 |
| 1995 | 2 | 0 |
| 1997 | 2 | 1 |
| 1998 | 2 | 0 |
| 2000 | 2 | 0 |
| 2001 | 1 | 0 |
| 2003 | 2 | 0 |
| 2006 | 1 | 0 |
| 2007 | 3 | 0 |
| 2008 | 2 | 1 |
| 2009 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 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.
3 devices in this family have a Class I recall. 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 1…l Name; Closed System Drug Transfer Device Classification Names: 21 CFR 880.5440. Closed System Drug Transfer Device, Product Code: B80ONB and 80FPA. : Predicate Device: K123213 BD Phaseal Closed System Drug Transfer Device K081361 ChemoClave Cytotoxic Medication Preparation and Delivery System . K082806… | 2013 |
| * | K081361 | Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXSummary page 1…on Names: 21 CFR 880.5440. Closed System Drug Transfer Device, Product Code: B80ONB and 80FPA. : Predicate Device: K123213 BD Phaseal Closed System Drug Transfer Device K081361 ChemoClave Cytotoxic Medication Preparation and Delivery System . K082806 Spinning Spiros Device Description; The ChemoLock is a… | 2008 |
| * | K082806 | Spinning Spiros, Model CH-2000Summary page 1…e: B80ONB and 80FPA. : Predicate Device: K123213 BD Phaseal Closed System Drug Transfer Device K081361 ChemoClave Cytotoxic Medication Preparation and Delivery System . K082806 Spinning Spiros Device Description; The ChemoLock is a needlefree, single-use, Closed System Drug Transfer Device (CSTD), The Ch… | 2009 |
What descends from it? (10)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K141448 | Tevadaptor Closed Drug Reconstitution and Transfer System | 2015 | 9 |
Has anything in its family been recalled? (3 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| May 12, 2026 | Class II | Z-3159-2026 | Process control | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall that does not enter the fluid… |
| May 12, 2026 | Class II | Z-3161-2026 | Process control | Intravascular administration tubing set drip chambers may have black specks potentially due to the plastic molding process leaving discolored polyvinyl chloride (PVC) material within the drip chamber wall. The presence of discoloration… |
| Mar 24, 2026 | Class II | Z-2210-2026 | Process control | Oncology sets/closed system transfer devices with extension sets may leak resulting in therapy delayed if noticed and corrected during setup, but if the leak occurs during therapy this may result in therapy interruption with the potential… |
| Sep 8, 2025 | Class II | Z-0340-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0352-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0333-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0336-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0343-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0358-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0348-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0347-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0341-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0335-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0357-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0351-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0342-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0356-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0344-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0350-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0354-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0360-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0359-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0346-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0338-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0361-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0362-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0329-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0337-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0330-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0349-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0328-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0353-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0339-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0365-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0334-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0355-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0345-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0331-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0364-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0363-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Sep 8, 2025 | Class II | Z-0332-2026 | Under Investigation by firm | Port weld of drug transfer device may separate or break during use and potentially result in a leak. |
| Nov 6, 2024 | Class II | Z-0652-2025 | Packaging process control | Due to finished goods incorrectly packaged and labeled. |
| Jun 27, 2022 | Class II | Z-1681-2022 | Component design/selection | Ports have a potential for unintended disconnection, inability to connect to or fully engage with injectors, due to a variation in the spring inside the Port, which may cause delay of therapy and exposure to caustic substances. Ports… |
| Mar 16, 2021 | Class II | Z-1574-2021 | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. |
| Mar 16, 2021 | Class II | Z-1572-2021 | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. |
| Mar 16, 2021 | Class II | Z-1575-2021 | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. |
| Mar 16, 2021 | Class II | Z-1571-2021 | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. |
| Mar 16, 2021 | Class II | Z-1570-2021 | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. |
| Mar 16, 2021 | Class II | Z-1573-2021 | Component design/selection | Due to molding defect, there is a potential that certain lots of spinning and non-spinning Sprios male luers may exhibit small amounts of leakage in the inactivated position. |
| Aug 31, 2020 | Class II | Z-0703-2021 | Process control | Potential for spinning versions of male luers to exhibit leaks due to a molding defect. Fluid leakage may potentially cause delay of infusion, contamination of the fluid path, exposure to hazardous medications, blood loss, exposure to… |
The 5 latest of 50 recalls; the web page lists all.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K081361Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXXIcu Medical, Inc. · 2008 · Direct predicate · ◆ in the 2008 ancestors bar of FIG. 12 Class I recalls
- K964435Primary IV SetIcu Medical, Inc. · 1997 · 2 generations back · ◆ in the 1997 ancestors bar of FIG. 15 Class I recalls
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.
- 9 of the 31 ancestors have a recall of any class; 2 have a Class I recall.
- 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
2007high 8 (2024) · low 0 (2007)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · ONB
60in 2025
2007high 277 (2021) · low 58 (2013)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · ONB
38in 2025
2007high 38 (2025) · low 0 (2007)2026
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · ONB
934in 2025
2007high 934 (2025) · low 0 (2007)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 ChemoLock Closed System Drug Transfer Device prevents the transfer of environmental contaminants, including bacterial and airborne contaminants into the system, and the escape of drug or vapor concentrations outside the system. The ChemoLock is needlefree and cannot be deactivated, which will passively aid in preventing needlestick injuries and the exposure to cytotoxic medications for healthcare personnel.
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/K131549 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131549: Chemolock, Chemolock Port.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131549
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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