510(k) · Cleared
ClearedCuros Jet Disinfecting Cap
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
3M Company · QBP Cap, Device Disinfectant
Cleared on Oct 29, 2020 as substantially equivalent to K111992 (Ivera Medical, Inc., 2012) after a 266-day review. Its family tree reaches back 5 generations to 2003.
- Decided
- Oct 29, 2020
- Review
- 266 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 deviceK200299 Curos Jet Disinfecting Cap3M Company · 2020
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) | K200299 | Curos Jet Disinfecting Cap | 3M Company | 2020 | — |
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…el: General Hospital Predicate/Reference Devices Same regulatory classifications for Predicate/Reference Devices as the Subject Device above: Predicate Device: K111992 – 3M™ Curos™ Disinfecting Cap Reference Device: K121171 – 3M™ Curos Tips™ Disinfecting Cap Device Description The 3M™ Curo… | 2012 |
| † | K121171 | Curos Tip | 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 17 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. 2020, 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?
The Curos Jet™ Disinfecting Cap is intended for use on needleless connectors only as a disinfecting cleaner prior to L.V. access and to act as a cover between line accesses. The cap will disinfect the needleless connector one (1) minute after application and protect from contamination between accesses for up to seven (7) days if not removed. The effectiveness of the cap was tested in vitro against Staphylococcus aureus, Staphylococcus epidermidis, Escherichia coli, Pseudomonas aeruginosa, Candida glabrata, and Candida albicans and was found to have >4 log reduction. The cap may be used in the home or healthcare facility.
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/K200299 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200299: Curos Jet Disinfecting Cap.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200299
Report an extraction error
Are you the manufacturer?
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