510(k) Report

510(k) · Cleared

Cleared

DualCap

K142806510(k) TraditionalCleared May 22, 2015235-day reviewClass II21 CFR 880.5440

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

Catheter Connections, Inc. · QBP Cap, Device Disinfectant

Cleared on May 22, 2015 as substantially equivalent to K093229 (Catheter Connections, Inc., 2010) after a 235-day review. Its family tree reaches back 5 generations to 2003. 1 later device descends from it.

Decided
May 22, 2015
Review
235 days
Class
Class II
Product code
QBP
Recalls
None
Predicates
1

Its longest line of descent runs back 5 generations to K030467 (2003). 8 ancestors in all, the oldest K833182 (1983). 1 later device descends from it, 1 citing it directly.

  1. Root · 5 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
  2. 4 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
  3. 3 generations backK080579 Effectiv (TM) CapHospira, Inc. · 2008
  4. 2 generations backK083508 SwabcapExcelsior Medical Corp. · 2009
  5. 1 generation backK093229 Catheter Connections DualcapCatheter Connections, Inc. · 2010
  6. This deviceK142806 DualCapCatheter Connections, Inc. · 2015
  7. Descendant · cites it directly · 0 of its ownK151620 Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc. · 2016

Most influential descendants

Showing 1 of 1 · See all
  • K151620Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc. · 2016 · cites it directly0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−5K030467Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension SetIv Medical, Inc.2003—
−4K063239Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528…Hospira, Inc.20067
−3K080579Effectiv (TM) CapHospira, Inc.2008—
−2K083508SwabcapExcelsior Medical Corp.2009—
−1K093229Catheter Connections DualcapCatheter Connections, Inc.2010—
0 (this device)K142806DualCapCatheter Connections, Inc.2015—
+1K151620Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc.2016—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
198310
199810
200810

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201610
FIG. 1 — Lineage of K142806, 2003–2016Source: 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), 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 QBP? 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 QBP device

  1. #1 K251592 SteriHub™ Disinfecting Device and Protective…score 12.3 · 6 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? (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.

TypeNumberDeviceApplicantDecidedRecalls
*K093229Catheter Connections Dualcap
Summary page 4
…Class: Unclassified Classification Product Code: LKB Classification Advisory Panel: General Hospital PREDICATE DEVICE: Catheter Connections’ DualCap® (K093229): (This predicate device has not been subject to a design-related recall) (No reference devices were used in this submission)…
Catheter Connections, Inc.2010—

Also cleared against K093229: 4 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K151620Firefly Peritoneal Dialysis Connector Disinfection SystemPuracath Medical, Inc.20160

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 12 years and passes through 4 companies; a new generation was cleared every 1.8 years on median.
  • 1 of the 8 ancestors has a recall of any class.
  • Of its descendants, K151620 (Puracath Medical, Inc., 2016) has gone furthest, with 0 descendants of its own.
  • 4 other devices also cite its predicate K093229.

How does its category compare?

All QBP devices

QBP Cap, Device Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.

FDA decisions per year · QBP

1in 2024

2008: 22009: 12010: 12011: 22012: 42013: 22014: 22015: 12020: 42024: 12026 (partial year): 2
2007high 4 (2012) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · QBP

299in 2020

2012: 129 days median2020: 299 days median
2007high 299 (2020) · low 129 (2012)2026

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

Recalls per year · QBP

No recall names QBP since 2007.

Adverse event reports per year · QBP

14in 2025

2019: 32021: 12023: 12024: 12025: 14
2007high 14 (2025) · low 0 (2007)2025

MAUDE reports naming product code QBP, 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
20070—00
20082—00
20091—00
20101—00
20112—00
2012412900
20132—00
20142—00
20151—00
20160—00
20170—00
20180—00
20190—03
2020429900
20210—01
20220—00
20230—01
20241—01
20250—014
20262—0—

What is it indicated for?

When left in place for 30 seconds the Light Blue DualCap® disinfects needleless luer access valves and the Dark Blue DualCap® disinfects the IV administration line male luer connections; thereafter the caps provide a physical barrier to contamination up to 7 days, under normal conditions if not removed.

Indications for use as stated in the FDA summary.

Cite this page

510(k) Report. “K142806: DualCap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K142806

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
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026