510(k) · Cleared
ClearedCLC2000 Catheter Patency Device
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 Dec 4, 2003 as substantially equivalent to K973167 (Icu Medical, Inc., 1997) after a 561-day review. Its family tree reaches back 3 generations to 1995. 29 later devices descend from it.
- Decided
- Dec 4, 2003
- Review
- 561 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K942988 (1995). 4 ancestors in all. 29 later devices descend from it, 1 citing it directly.
- Root · 3 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 2 generations backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- 1 generation backK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- This deviceK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- Descendant · cites it directly · 28 of its ownK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
- Descendant · 2 generations on · 26 of its ownK132413 MZ1000Care Fusion · 2013
- Descendant · 3 generations on · 13 of its ownK140831 Maxzero Extension Set with Needless ConnectorCare Fusion · 2014
- Descendant · 3 generations on · 6 of its ownK170336 BD Nexiva Closed IV Catheter System (Single Port) with MaxZero…Becton, Dickinson and Company · 2017
- Descendant · 4 generations on · 5 of its ownK183399 BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · Recalled
Showing 5 of 29 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 29 · See all- K100434Clave NeutronIcu Medical, Inc. · 2010 · cites it directly28descendants
- K132413MZ1000Care Fusion · 2013 · 2 generations on26descendants
- K140831Maxzero Extension Set with Needless ConnectorCare Fusion · 2014 · 3 generations on13descendants
- K170336BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless ConnectorBecton, Dickinson and Company · 2017 · 3 generations on6descendants
- K183399BD Nexiva Closed IV Catheter SystemBecton Dickinson Infusion Therapy Systems, Inc. · 2019 · 4 generations on5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −2 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| −1 | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| 0 (this device) | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| +1 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
| +2 | K132413 | MZ1000 | Care Fusion | 2013 | — |
| +3 | K140831 | Maxzero Extension Set with Needless Connector | Care Fusion | 2014 | — |
| +3 | K170336 | BD Nexiva Closed IV Catheter System (Single Port) with MaxZero Needleless… | Becton, Dickinson and Company | 2017 | — |
| +4 | K183399 | BD Nexiva Closed IV Catheter System | Becton Dickinson Infusion Therapy Systems, Inc. | 2019 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K973167 | Positive Pressure ConnectorSummary page 1…ce Common Name: Accessory, Intravenous Administration Device Classification Name: Same Equivalent Device: ICU Medical CLC2000 (K973167) B.Braun Safsite® (5110(K) number unknown) Device Description: The CLC2000 is a swab-able normally closed tw… | 1997 |
| * | — | B.Braun Safsite Named without a submission number |
What descends from it? (29)
See all 291 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K100434 | Clave Neutron | 2010 | 28 |
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 8 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 4 ancestors have a recall of any class.
- Of its descendants, K100434 (Icu Medical, Inc., 2010) has gone furthest, with 28 descendants of its own.
- 1 other device also cites its predicate K973167.
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
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?
The CLC2000 is intended for use as an accessory to a vascular access device. The CLC2000 has been shown to reduce thrombotic occlusion within the internal catheter lumen and fibrin formation in an animal study. The CLC2000 is designed to assist in maintaining catheter patency. The CLC2000 does not require the use of needles and therefore will passively aid in the reduction of needlestick injuries.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K021692 · printed Nov 4, 2026
Cite this page
510(k) Report. “K021692: CLC2000 Catheter Patency Device.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021692
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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