510(k) · Cleared
Recalled · Class II · 2022Clave Connector
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 Jun 24, 1997 after a 106-day review. The FDA summary names its predicate without a number. 2 of the 83 devices in its family, counting itself, have a Class I recall. 82 later devices descend from it. It has been recalled 52 times.
- Decided
- Jun 24, 1997
- Review
- 106 days
- Class
- Class II
- Product code
- FPA
- Recalls
- 52
- Predicates
- 0
82 later devices descend from it, 15 citing it directly. 2 of the 83 devices in this family, counting this one, have a Class I recall.
- This deviceK970855 Clave ConnectorIcu Medical, Inc. · 1997
- Descendant · cites it directly · 35 of its ownK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- Descendant · 2 generations on · 31 of its ownK991653 Invision-Plus Injection Port Connector SystemRymed Technologies, Inc. · 1999 · Recalled
- Descendant · 2 generations on · 29 of its ownK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- Descendant · 3 generations on · 28 of its ownK120443 Neutral Luer Activated Device and Extension Sets with Neutral Luer…Baxter Healthcare Corporation - Renal Division · 2012
- Descendant · cites it directly · 28 of its ownK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
Showing 5 of 82 descendants. See all descendants
Descendants cleared per year
1997high 9 (2021) · low 0 (1998)2026
Class I recalls in this family
Most influential descendants
Showing 5 of 82 · See all- K973167Positive Pressure ConnectorIcu Medical, Inc. · 1997 · cites it directly35descendants
- K991653Invision-Plus Injection Port Connector SystemRymed Technologies, Inc. · 1999 · 2 generations on31descendants
- K021692CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003 · 2 generations on29descendants
- K120443Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated DeviceBaxter Healthcare Corporation - Renal Division · 2012 · 3 generations on28descendants
- K100434Clave NeutronIcu Medical, Inc. · 2010 · cites it directly28descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K970855 | Clave Connector | Icu Medical, Inc. | 1997 | — |
| +1 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| +2 | K991653 | Invision-Plus Injection Port Connector System | Rymed Technologies, Inc. | 1999 | 4 |
| +2 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| +3 | K120443 | Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated… | Baxter Healthcare Corporation - Renal Division | 2012 | — |
| +1 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 1999 | 2 | 0 |
| 2002 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2007 | 1 | 0 |
| 2008 | 3 | 1 |
| 2009 | 3 | 0 |
| 2010 | 4 | 0 |
| 2011 | 1 | 0 |
| 2012 | 3 | 0 |
| 2013 | 4 | 1 |
| 2014 | 5 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 8 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 3 | 0 |
| 2021 | 9 | 0 |
| 2022 | 4 | 0 |
| 2023 | 7 | 0 |
| 2024 | 3 | 0 |
| 2025 | 7 | 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.
2 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 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? (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 |
|---|---|---|---|
| * | — | IVAC SmartSite™ Named without a submission number |
What descends from it? (82)
See all 8215 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K973167 | Positive Pressure Connector | 1997 | 35 |
| K100434 | Clave Neutron | 2010 | 28 |
| K051437 | CML 1000 | 2005 | 16 |
| K081361 | Chemoclave Cytotoxic Medication Preparation and Delivery System, Model, CH-XXXX Class I | 2008 | 12 |
| K120799 | Arisure Neutral Valve | 2012 | 2 |
| K013621 | BD Saf-T PRN Luer Activated Valve, Model 385100 | 2002 | 2 |
| K030246 | Victus I.V. Administration Set, Models 27071 and 27072 | 2003 | 1 |
| K984060 | Luer Access Injection Site | 1999 | 1 |
| K220267 | AMSafe NeuFlo Needleless Connector | 2022 | 0 |
| K213004 | Needle Free Connector | 2022 | 0 |
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 1, 2022 | Class II | Z-1722-2022 | Process control | Due to a manufacturing defect which results in a visible gap between the connector's top and bottom housing. |
| Dec 24, 2013 | Class II | Z-0697-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0674-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0689-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0694-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0670-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0682-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0661-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0663-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0707-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0702-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0686-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0668-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0671-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0692-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0678-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0695-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0687-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0673-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0706-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0699-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0700-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0675-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0664-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0704-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0705-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0684-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0667-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0690-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0685-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0703-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0669-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0672-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0666-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0677-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0691-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0681-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0701-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0683-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0696-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0688-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0659-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0693-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0698-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0679-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0662-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0658-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0660-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0676-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
| Dec 24, 2013 | Class II | Z-0665-2014 | Equipment maintenance | ICU Medical is recalling certain lots of the NanoClave Needlefree Connector product line because of a small percentage of devices that may leak. |
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 · Cites it directly · ◆ in the 2008 descendants bar of FIG. 12 Class I recalls
- K131549Chemolock, Chemolock PortIcu Medical, Inc. · 2013 · 2 generations on · ◆ in the 2013 descendants bar of FIG. 12 Class I recalls
What does this lineage say?
- Of its descendants, K973167 (Icu Medical, Inc., 1997) has gone furthest, with 35 descendants of its own.
How does its category compare?
All FPA devicesFPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FPA
11in 2025
2007high 23 (2010) · low 4 (2018)2026
2026 to Oct 25, outlined.
Median 510(k) review, days · FPA
225in 2025
2007high 340 (2023) · low 75 (2007)2026
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FPA
98in 2025
2007high 166 (2009) · low 1 (2021)2026
Class I (17 since 2007) Class II/III not classified
Adverse event reports per year · FPA
34,506in 2025
2007high 47,210 (2024) · low 1,499 (2007)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?
The ICU Needleless Conngector is a single use, sterile, non-pyrogenic device intended for use as an accessory to intravascular administration set for the administration of fluids to a patient through a cannula placed in the vein or artery.
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/K970855 · printed Nov 5, 2026
Cite this page
510(k) Report. “K970855: Clave Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K970855
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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