510(k) · Cleared
ClearedACTIV™ Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cleansite Medical, Inc. · QBP Cap, Device Disinfectant
Cleared on Apr 5, 2024 as substantially equivalent to K111992 (Ivera Medical, Inc., 2012) after a 463-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Apr 5, 2024
- Review
- 463 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). No later device cites it as a predicate yet.
- Root · 5 generations backK030467 Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller…Iv Medical, Inc. · 2003
- 4 generations backK063239 Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models…Hospira, Inc. · 2006 · Recalled
- 3 generations backK080579 Effectiv (TM) CapHospira, Inc. · 2008
- 2 generations backK083508 SwabcapExcelsior Medical Corp. · 2009
- 1 generation backK111992 Curos Port ProtectorIvera Medical, Inc. · 2012
- This deviceK223914 ACTIV™ CapCleansite Medical, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K030467 | Gravitech TM Flow Controller Primary Set/Gravitech Flow Controller Extension Set | Iv Medical, Inc. | 2003 | — |
| −4 | K063239 | Lifeshield Latex-Free Gravitech Flow Controller I.V. Sets, Models 17528… | Hospira, Inc. | 2006 | 7 |
| −3 | K080579 | Effectiv (TM) Cap | Hospira, Inc. | 2008 | — |
| −2 | K083508 | Swabcap | Excelsior Medical Corp. | 2009 | — |
| −1 | K111992 | Curos Port Protector | Ivera Medical, Inc. | 2012 | — |
| 0 (this device) | K223914 | ACTIV™ Cap | Cleansite Medical, Inc. | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 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 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 K251592 SteriHub™ Disinfecting Device and Protective…score 12.3 · 6 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 |
|---|---|---|---|
| * | K111992 | Curos Port ProtectorSummary page 5…Code Number Date Curos Port Cap, Device Disinfectant/ Unclassified QBP K111992 1/12/2012 Protector Device Description The Subject Device is a sterile, single-use device that is us… | 2012 |
What descends from it?
No later submission names this one as a predicate yet.
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 21 years and passes through 5 companies; a new generation was cleared every 2.7 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 4 other devices also cite its predicate K111992.
How does its category compare?
All QBP devicesQBP Cap, Device Disinfectant: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · QBP
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · QBP
299in 2020
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
MAUDE reports naming product code QBP, 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 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 1 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 2 | — | 0 | 0 |
| 2012 | 4 | 129 | 0 | 0 |
| 2013 | 2 | — | 0 | 0 |
| 2014 | 2 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 3 |
| 2020 | 4 | 299 | 0 | 0 |
| 2021 | 0 | — | 0 | 1 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 1 |
| 2024 | 1 | — | 0 | 1 |
| 2025 | 0 | — | 0 | 14 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
ACTIV Cap is intended for use on a needleless vascular access port as an active cleaning and disinfecting device prior to IV access and to act as a passive, protective barrier for up to 7 days if not removed. ACTIV Cap disinfects needleless vascular access ports in one (1) minute after application and achieves at least a >5-log reduction as tested in vitro against 6 organisms - Staphylococcus aureus, Staphylococcus epidermis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K223914 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223914: ACTIV™ Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K223914
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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