510(k) Report

510(k) · Cleared

Recalled · 2003

Clave Connector

K915571510(k) TraditionalCleared Sep 21, 1992284-day reviewClass II21 CFR 880.5440Recalls 3

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Icu Medical, Inc. · FPA Set, Administration, Intravascular

Cleared on Sep 21, 1992 after a 284-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 17 later devices descend from it. It has been recalled 3 times.

Decided
Sep 21, 1992
Review
284 days
Class
Class II
Product code
FPA
Recalls
3
Predicates
0

17 later devices descend from it, 7 citing it directly.

Descendants, by year cleared 2003: 2 descendants cleared1999: 1 descendant cleared2008: 2 descendants cleared1998: 4 descendants cleared1996: 1 descendant cleared2010: 2 descendants cleared1997: 1 descendant cleared2007: 1 descendant cleared2004: 1 descendant cleared2009: 1 descendant cleared2011: 1 descendant cleared1990200020102020
  1. This deviceK915571 Clave ConnectorIcu Medical, Inc. · 1992
  2. Descendant · cites it directly · 5 of its ownK973916 NP Medical Capless Luer Activated ValveNp Medical, Inc. · 1998
  3. Descendant · 2 generations on · 4 of its ownK072576 Clearlink Antimicrobial Luer Activated Device (Lad) and Extension…Baxter Healthcare Corp · 2007
  4. Descendant · cites it directly · 4 of its ownK960661 Maxcess Needle Free Connector (8200)Solopak Medical Products, Inc. · 1996
  5. Descendant · 3 generations on · 3 of its ownK081289 V-Link Antimicrobial Luer Activated Device and Extension Sets with…Baxter Healthcare Corp · 2008
  6. Descendant · cites it directly · 1 of its ownK030246 Victus I.V. Administration Set, Models 27071 and 27072Victus, Inc. · 2003

Showing 5 of 17 descendants. See all descendants

Descendants cleared per year

1996: 11997: 11998: 41999: 12003: 22004: 12007: 12008: 22009: 12010: 22011: 1
1996high 4 (1998) · low 0 (2000)2026

Most influential descendants

Showing 5 of 17 · See all
  • K973916NP Medical Capless Luer Activated ValveNp Medical, Inc. · 1998 · cites it directly5descendants
  • K072576Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with the…Baxter Healthcare Corp · 2007 · 2 generations on4descendants
  • K960661Maxcess Needle Free Connector (8200)Solopak Medical Products, Inc. · 1996 · cites it directly4descendants
  • K081289V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link Antimicrobial…Baxter Healthcare Corp · 2008 · 3 generations on3descendants
  • K030246Victus I.V. Administration Set, Models 27071 and 27072Victus, Inc. · 2003 · cites it directly1descendant
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K915571Clave ConnectorIcu Medical, Inc.1992—
+1K973916NP Medical Capless Luer Activated ValveNp Medical, Inc.1998—
+2K072576Clearlink Antimicrobial Luer Activated Device (Lad) and Extension Sets with…Baxter Healthcare Corp2007—
+1K960661Maxcess Needle Free Connector (8200)Solopak Medical Products, Inc.1996—
+3K081289V-Link Antimicrobial Luer Activated Device and Extension Sets with V-Link…Baxter Healthcare Corp2008—
+1K030246Victus I.V. Administration Set, Models 27071 and 27072Victus, Inc.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
199610
199710
199840
199910
200320
200410
200710
200820
200910
201020
201110
FIG. 1 — Lineage of K915571, 1992–2011Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), 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. #1 K243841 Sparta Infusion Set for Insulinscore 13.4 · 3 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against?

FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

What descends from it? (17)

See all 17

7 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K973916NP Medical Capless Luer Activated ValveNp Medical, Inc.19985
K960661Maxcess Needle Free Connector (8200)Solopak Medical Products, Inc.19964
K030246Victus I.V. Administration Set, Models 27071 and 27072Victus, Inc.20031
K984060Luer Access Injection SiteBaxter Healthcare Corp19991
K080007Graduated Adapter with ClaveIcu Medical, Inc.20080
K033576Lifeshield Latex-Free Primary IV Pump Set Distal Microbore Patient Line, Convertible…Abbott Laboratories20030
K981548NFC Needlefree Connector Model 69900Filtertek, Inc.19980

Has anything in its family been recalled? (0 Class I)

Recalls of this device

DateClassRecallRoot causeReason
Jun 9, 2003Not classifiedZ-0956-03OtherThe drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
Jun 9, 2003Not classifiedZ-0955-03OtherThe drip chambers and/or adapters in the sets were manufactured with non-radiation grade plastic resin, resulting in discoloration of the resin.
May 13, 2003Not classifiedZ-0914-03OtherIV Burette administration sets are mislabeled as having pre-pierced injection sites, when the injection sites are not pre-pierced.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • Of its descendants, K973916 (Np Medical, Inc., 1998) has gone furthest, with 5 descendants of its own.

How does its category compare?

All FPA devices

FPA Set, Administration, Intravascular: FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · FPA

11in 2025

2007: 162008: 182009: 102010: 232011: 122012: 212013: 132014: 222015: 172016: 122017: 172018: 42019: 72020: 102021: 132022: 142023: 142024: 72025: 112026 (partial year): 5
2007high 23 (2010) · low 4 (2018)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FPA

225in 2025

2007: 75 days median2008: 89 days median2009: 166 days median2010: 120 days median2011: 87 days median2012: 96 days median2013: 90 days median2014: 89 days median2015: 123 days median2016: 195 days median2017: 240 days median2018: 177 days median2019: 161 days median2020: 327 days median2021: 186 days median2022: 213 days median2023: 340 days median2024: 244 days median2025: 225 days median2026 (partial year): 266 days median
2007high 340 (2023) · low 75 (2007)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FPA

98in 2025

2007: 172008: 152009: 1662010: 582011: 282012: 16, 4 Class I2013: 642014: 242015: 62016: 102017: 132018: 42019: 132020: 1072021: 12022: 9, 5 Class I2023: 12, 4 Class I2024: 13, 1 Class I2025: 98, 1 Class I2026 (partial year): 10, 2 Class I
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

2007: 1,4992008: 1,9412009: 2,5122010: 2,5372011: 4,4072012: 4,9302013: 4,6512014: 4,6952015: 6,6252016: 8,4702017: 6,4622018: 6,5742019: 11,2272020: 9,5632021: 10,4142022: 13,3932023: 10,9162024: 47,2102025: 34,506
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20071675171,499
20081889151,941
2009101661662,512
201023120582,537
20111287284,407
2012219616 (4)4,930
20131390644,651
20142289244,695
20151712366,625
201612195108,470
201717240136,462
2018417746,574
201971611311,227
2020103271079,563
202113186110,414
2022142139 (5)13,393
20231434012 (4)10,916
2024724413 (1)47,210
20251122598 (1)34,506
2026526610 (2)—

More from Icu Medical, Inc.

66 FDA decisions under this applicant name. See the company

  • K252130LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 2026
  • K252006OTTO™ Disinfecting CapIcu Medical, Inc. · 2026
  • K251980ClaveQS™ BagIcu Medical, Inc. · 2026
  • K250616Clave™ Neutral-Displacement Needlefree ConnectorsIcu Medical, Inc. · 2025
  • K242117LifeShield Infusion Safety Software SuiteIcu Medical, Inc. · 20252 recalls

Recent decisions in FPA

The FPA category page

  • K260261Gravity Blood Sets with 200µm FilterB.Braun Medical, Inc. · 2026
  • K254123Ecomed Disposable Administration SetsEcomed Solutions, LLC · 2026
  • K261530iiSure Infusion SetDeka Research and Development · 2026
  • K252543AMSafe Administration Set (BA-70075, BA-70071-D, BA-70070, BA-70071-P, BA-70072, BA-70072-F, BA-70071-DF…Amsino International, Inc. · 2026
  • K251375PuraCath Firefly Needleless Connector IT (9005)Puracath Medical, Inc. · 2026

https://510kreport.com/device/K915571 · printed Nov 6, 2026

Cite this page

510(k) Report. “K915571: Clave Connector.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K915571

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

Record history
  • FDA decision record loaded May 2, 2026
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026