510(k) · Cleared
Recalled · Class II · 2022Clave Neutron
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Icu Medical, Inc. · FPA Set, Administration, Intravascular
Cleared on Jul 9, 2010 as substantially equivalent to K970855 (Icu Medical, Inc., 1997) and 2 other predicates after a 143-day review. Its family tree reaches back 4 generations to 1995. 28 later devices descend from it. It has been recalled 3 times.
- Decided
- Jul 9, 2010
- Review
- 143 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 4 generations to K942988 (1995). 7 ancestors in all. 28 later devices descend from it, 2 citing it directly.
- Root · 4 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 3 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 2 generations backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- 1 generation backK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- This deviceK100434 Clave NeutronIcu Medical, Inc. · 2010
- Descendant · cites it directly · 26 of its ownK132413 MZ1000Care Fusion · 2013
- Descendant · 2 generations on · 13 of its ownK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- Descendant · 2 generations on · 6 of its ownK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
- Descendant · 3 generations on · 5 of its ownK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · Recalled
- Descendant · 3 generations on · 4 of its ownK162804 Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017
Showing 5 of 28 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 28 · See all- K132413MZ1000Care Fusion · 2013 · cites it directly26descendants
- K140831Maxzero Extension Set with Needless ConnectorCare Fusion · 2014 · 2 generations on13descendants
- K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company · 2017 · 2 generations on6descendants
- K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · 3 generations on5descendants
- K162804Q2 Low Pressure Power Injection Extension SetQuest Medical, Inc. · 2017 · 3 generations on4descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −3 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −2 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| −1 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| 0 (this device) | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | — |
| +1 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| +2 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| +2 | K170336 | BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless… | Becton, Dickinson and Company | 2017 | — |
| +3 | K183399 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2019 | 3 |
| +3 | K162804 | Q2 Low Pressure Power Injection Extension Set | Quest Medical, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2003 | 1 | 0 |
| 2009 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2021 | 6 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 FPA? 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 FPA device
- #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 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 |
|---|---|---|---|
| * | K970855 | Clave ConnectorSummary page 1…nnector, Closed Access Classiflcation Name: 21 CFR 880.5440, Class Il Device, 80FPA & 80LHI, Accessory Legally Marketed Predicate Devices for Substantial Equivalence; *K970855 — CLAVE® Connector — ICU Medical Inc. *K021692 —~ CLC2000°® Catheter Patency Device ~ ICU Medical, Inc. *K083723 ~ A6 Luer Access… | 1997 |
| * | K021692 | CLC2000 Catheter Patency DeviceSummary page 1…CFR 880.5440, Class Il Device, 80FPA & 80LHI, Accessory Legally Marketed Predicate Devices for Substantial Equivalence; *K970855 — CLAVE® Connector — ICU Medical Inc. *K021692 —~ CLC2000°® Catheter Patency Device ~ ICU Medical, Inc. *K083723 ~ A6 Luer Access Device - B, Braun Medical, Inc. Rationale for… | 2003 |
| * | K083723 | A6 Luer Access DeviceSummary page 1…arketed Predicate Devices for Substantial Equivalence; *K970855 — CLAVE® Connector — ICU Medical Inc. *K021692 —~ CLC2000°® Catheter Patency Device ~ ICU Medical, Inc. *K083723 ~ A6 Luer Access Device - B, Braun Medical, Inc. Rationale for Substantial Equivalence: The CLAVE Neutron is substantially equi… | 2009 |
What descends from it? (28)
See all 282 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 1, 2022 | Class II | Z-1719-2022 | Process control | Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. |
| Jul 6, 2020 | Class II | Z-0182-2021 | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. |
| Jul 6, 2020 | Class II | Z-0261-2021 | Process control | Identification of a potential manufacturing defect on the internal surface of the NanoClave within specific lots of NanoClave sets, which may inhibit a proper seal with the NanoClave spike. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 3 companies; a new generation was cleared every 6.0 years on median.
- 4 of the 7 ancestors have a recall of any class.
- Of its descendants, K132413 (Care Fusion, 2013) has gone furthest, with 26 descendants of its own.
- 14 other devices also cite its predicate K970855.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, this device’s year, is highlighted.
FDA decisions per year · FPA
11in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
MAUDE reports naming product code FPA, 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 | 16 | 75 | 17 | 1,499 |
| 2008 | 18 | 89 | 15 | 1,941 |
| 2009 | 10 | 166 | 166 | 2,512 |
| 2010 | 23 | 120 | 58 | 2,537 |
| 2011 | 12 | 87 | 28 | 4,407 |
| 2012 | 21 | 96 | 16 (4) | 4,930 |
| 2013 | 13 | 90 | 64 | 4,651 |
| 2014 | 22 | 89 | 24 | 4,695 |
| 2015 | 17 | 123 | 6 | 6,625 |
| 2016 | 12 | 195 | 10 | 8,470 |
| 2017 | 17 | 240 | 13 | 6,462 |
| 2018 | 4 | 177 | 4 | 6,574 |
| 2019 | 7 | 161 | 13 | 11,227 |
| 2020 | 10 | 327 | 107 | 9,563 |
| 2021 | 13 | 186 | 1 | 10,414 |
| 2022 | 14 | 213 | 9 (5) | 13,393 |
| 2023 | 14 | 340 | 12 (4) | 10,916 |
| 2024 | 7 | 244 | 13 (1) | 47,210 |
| 2025 | 11 | 225 | 98 (1) | 34,506 |
| 2026 | 5 | 266 | 10 (2) | — |
What is it indicated for?
CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. The device may also be used with power injector procedures up to 10mL per second of contrast media and a maximum pressure of 350psi. The device incorporates a technology that…
Read the full statement (130 words)
CLAVE Neutron is a normally closed, bidirectional connector intended for use as an accessory to an intravascular catheter placed in the vein or artery. The device may be used for the administration of blood and fluids to patients, including pediatrics and immunocompromised patients. The device may also be used with power injector procedures up to 10mL per second of contrast media and a maximum pressure of 350psi. The device incorporates a technology that will prevent fluid displacement resulting from the following: Connection or disconnection of a luer; syringe plunger compression; patient vascular pressure changes, such as coughing or sneezing; and IV solution container run-dry. The CLAVE Neutron incorporates a pre-slit septum that does not require the use of needles and will therefore passively aid in the reduction of needlestick injuries.
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/K100434 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100434: Clave Neutron.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100434
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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