510(k) · Cleared
ClearedPositive Pressure 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 Nov 17, 1997 as substantially equivalent to K955585 (B.Braun Medical, Inc., 1996) and 1 other predicate after an 84-day review. Its family tree reaches back 2 generations to 1995. 35 later devices descend from it.
- Decided
- Nov 17, 1997
- Review
- 84 days
- Class
- Class II
- Product code
- FPA
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K942988 (1995). 3 ancestors in all. 35 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK942988 Filtered Extension SetsB. Braun of America, Inc. · 1995 · Recalled
- 1 generation backK955585 V2 Injection SiteB.Braun Medical, Inc. · 1996 · Recalled
- This deviceK973167 Positive Pressure ConnectorIcu Medical, Inc. · 1997
- Descendant · cites it directly · 31 of its ownK991653 Invision-Plus Injection Port Connector SystemRymed Technologies, Inc. · 1999 · Recalled
- Descendant · cites it directly · 29 of its ownK021692 CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003
- Descendant · 2 generations on · 28 of its ownK120443 Neutral Luer Activated Device and Extension Sets with Neutral Luer…Baxter Healthcare Corporation - Renal Division · 2012
- Descendant · 2 generations on · 28 of its ownK100434 Clave NeutronIcu Medical, Inc. · 2010 · Recalled
- Descendant · 3 generations on · 26 of its ownK132413 MZ1000Care Fusion · 2013
Showing 5 of 35 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 35 · See all- K991653Invision-Plus Injection Port Connector SystemRymed Technologies, Inc. · 1999 · cites it directly31descendants
- K021692CLC2000 Catheter Patency DeviceIcu Medical, Inc. · 2003 · cites it directly29descendants
- K120443Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated DeviceBaxter Healthcare Corporation - Renal Division · 2012 · 2 generations on28descendants
- K100434Clave NeutronIcu Medical, Inc. · 2010 · 2 generations on28descendants
- K132413MZ1000Care Fusion · 2013 · 3 generations on26descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K942988 | Filtered Extension Sets | B. Braun of America, Inc. | 1995 | 32 |
| −1 | K955585 | V2 Injection Site | B.Braun Medical, Inc. | 1996 | 27 |
| 0 (this device) | K973167 | Positive Pressure Connector | Icu Medical, Inc. | 1997 | — |
| +1 | K991653 | Invision-Plus Injection Port Connector System | Rymed Technologies, Inc. | 1999 | 4 |
| +1 | K021692 | CLC2000 Catheter Patency Device | Icu Medical, Inc. | 2003 | — |
| +2 | K120443 | Neutral Luer Activated Device and Extension Sets with Neutral Luer Activated… | Baxter Healthcare Corporation - Renal Division | 2012 | — |
| +2 | K100434 | Clave Neutron | Icu Medical, Inc. | 2010 | 3 |
| +3 | K132413 | MZ1000 | Care Fusion | 2013 | — |
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 |
|---|---|---|
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
| 2010 | 2 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 5 | 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 |
|---|---|---|---|
| * | K955585 | V2 Injection SiteSummary page 1…CLC 2000 Common Name: [ntravascular Administration Set Classification Name: Intravascular Administration Set Equivalent Device: : B. Braun V2 Ultrasite Injection Site (K955585) ICU Medical CLAVE Connector (K970855) Device Description: The CLC 2000 is a single use, sterile, hon-pyrogenic, swab-able, bi-d… | 1996 |
| * | K970855 | Clave ConnectorSummary page 1…dministration Set Classification Name: Intravascular Administration Set Equivalent Device: : B. Braun V2 Ultrasite Injection Site (K955585) ICU Medical CLAVE Connector (K970855) Device Description: The CLC 2000 is a single use, sterile, hon-pyrogenic, swab-able, bi-directional valve intended for use as a… | 1997 |
What descends from it? (35)
See all 352 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)
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 2 years and passes through 3 companies; a new generation was cleared every 1.5 years on median.
- 3 of the 3 ancestors have a recall of any class.
- Of its descendants, K991653 (Rymed Technologies, Inc., 1999) has gone furthest, with 31 descendants of its own.
- 6 other devices also cite its predicate K955585.
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 CLC 2000 is a single use, sterile, non-pyrogenic, swab-able, bi-directional valve intended for use as an accessory to Intravascular administration set. The CLC 2000 provides access for the administration of fluids from a container to a patient's vascular system through the administration set's needle or catheter (which is inserted into a vein or artery). The CLC 2000 also provides access for the withdrawal of fluids from a patient’s vascular system.
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/K973167 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973167: Positive Pressure Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973167
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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