510(k) · Cleared
ClearedConfluent Surgical Dual Liquid Applicator, Model 70-2005093
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Confluent Surgical,Inc · FMF Syringe, Piston
Cleared on Dec 9, 2004 after a 78-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 1 of the 4 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Dec 9, 2004
- Review
- 78 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
3 later devices descend from it, 1 citing it directly. 1 of the 4 devices in this family, counting this one, has a Class I recall.
- This deviceK042588 Confluent Surgical Dual Liquid Applicator, Model 70-2005093Confluent Surgical,Inc · 2004
- Descendant · cites it directly · 2 of its ownK061183 Confluent Surgical Dual Liquid Applicator, Model 70-2005-093Confluent Surgical,Inc · 2006
- Descendant · 2 generations on · 1 of its ownK072790 Confluent Surgical Extended Tip Applicator, Model 70-2008-008Confluent Surgical,Inc · 2008
- Descendant · 3 generations on · 0 of its ownK091315 Covidien Extended Tip ApplicatorConfluent Surgical,Inc · 2009 · Recalled (Class I)
Class I recalls in this family
- K091315 Covidien Extended Tip Applicator3 generations on · 2009
Most influential descendants
Showing 3 of 3 · See all- K061183Confluent Surgical Dual Liquid Applicator, Model 70-2005-093Confluent Surgical,Inc · 2006 · cites it directly2descendants
- K072790Confluent Surgical Extended Tip Applicator, Model 70-2008-008Confluent Surgical,Inc · 2008 · 2 generations on1descendant
- K091315Covidien Extended Tip ApplicatorConfluent Surgical,Inc · 2009 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K042588 | Confluent Surgical Dual Liquid Applicator, Model 70-2005093 | Confluent Surgical,Inc | 2004 | — |
| +1 | K061183 | Confluent Surgical Dual Liquid Applicator, Model 70-2005-093 | Confluent Surgical,Inc | 2006 | — |
| +2 | K072790 | Confluent Surgical Extended Tip Applicator, Model 70-2008-008 | Confluent Surgical,Inc | 2008 | — |
| +3 | K091315 | Covidien Extended Tip Applicator | Confluent Surgical,Inc | 2009 | Class I |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 1 |
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.
1 device in this family has a Class I recall. 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 FMF device
- #1 K241821 Luer Lock Syringe with Safety Needle; Luer…score 16.1 · 8 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K872526 | FDA’s K872526 is CT Pace Catalog Number B7950A Our reading of the summary gave K872526, FDA’s number for CT Pace Catalog Number B7950A (General Electric Co.). Its FDA name has none of the distinctive words the summary uses for the device it names, “DuoFlo Dispenser Kit”. Kept off the family tree. Summary page 1…ct Code: FMF Common Name Confluent Surgical Dual Liquid Applicator Predicate Device(s) DuoFlo Tm Dispenser Kit (K872526) DEVICE DESCRIPTION Product Description The Confluent Surgical Dual Liquid Applic… | 1987 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K061183 | Confluent Surgical Dual Liquid Applicator, Model 70-2005-093 | 2006 | 2 |
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K091315Covidien Extended Tip ApplicatorConfluent Surgical,Inc · 2009 · 3 generations on · ◆ in the 2009 descendants bar of FIG. 13 Class I recalls
What does this lineage say?
- Of its descendants, K061183 (Confluent Surgical,Inc, 2006) has gone furthest, with 2 descendants of its own.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · FMF
13in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FMF
114in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FMF
19in 2023
Class I (19 since 2007) Class II/III not classified
Adverse event reports per year · FMF
4,181in 2025
MAUDE reports naming product code FMF, 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 | 23 | 90 | 6 | 674 |
| 2008 | 9 | 74 | 11 | 691 |
| 2009 | 14 | 94 | 15 | 913 |
| 2010 | 11 | 130 | 12 | 679 |
| 2011 | 16 | 109 | 3 | 186 |
| 2012 | 9 | 86 | 6 | 307 |
| 2013 | 12 | 154 | 1 | 326 |
| 2014 | 13 | 84 | 1 | 244 |
| 2015 | 11 | 87 | 2 | 273 |
| 2016 | 12 | 146 | 0 | 684 |
| 2017 | 13 | 135 | 3 | 1,858 |
| 2018 | 8 | 87 | 2 | 3,952 |
| 2019 | 11 | 146 | 1 | 5,863 |
| 2020 | 15 | 107 | 2 | 5,334 |
| 2021 | 20 | 175 | 1 | 5,874 |
| 2022 | 24 | 211 | 2 | 5,233 |
| 2023 | 22 | 173 | 19 (18) | 5,214 |
| 2024 | 14 | 130 | 0 | 5,122 |
| 2025 | 13 | 114 | 0 | 4,181 |
| 2026 | 9 | 239 | 2 (1) | — |
What is it indicated for?
The Confluent Surgical Dual Liquid Applicator is indicated for use in the simultaneous delivery of two non-homogeneous fluids or solutions onto a surgical site.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K042588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K042588: Confluent Surgical Dual Liquid Applicator, Model 70-2005093.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K042588
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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