510(k) · Cleared
ClearedDuploreach
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Baxter Healthcare Corp · FMF Syringe, Piston
Cleared on Jun 7, 2002 as substantially equivalent to K992351 (Biosurgical Corp., 1999) after a 177-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Jun 7, 2002
- Review
- 177 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K964597 (1997). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK964597 Biosurgical, Corp. Multi Chamber Suction SyringeBiosurgical Corp. · 1997
- 1 generation backK992351 Sealouette Fibrin Sealant ApplicatorBiosurgical Corp. · 1999
- This deviceK014088 DuploreachBaxter Healthcare Corp · 2002
- Descendant · cites it directly · 0 of its ownK071126 Cryoseal FS Applicator SystemThermogenesis Corp. · 2007
Most influential descendants
Showing 1 of 1 · See all- K071126Cryoseal FS Applicator SystemThermogenesis Corp. · 2007 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K964597 | Biosurgical, Corp. Multi Chamber Suction Syringe | Biosurgical Corp. | 1997 | — |
| −1 | K992351 | Sealouette Fibrin Sealant Applicator | Biosurgical Corp. | 1999 | — |
| 0 (this device) | K014088 | Duploreach | Baxter Healthcare Corp | 2002 | — |
| +1 | K071126 | Cryoseal FS Applicator System | Thermogenesis Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 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 FMF? 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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K992351 | Sealouette Fibrin Sealant ApplicatorSummary page 1…ended Applicator CommonPUsuaV Syringe, Piston Classification Name Predicate Device SEALOUETTE Fibrin Sealant Applicator 51O(k) No. K992351 Baxter Healthcare Corporation, Baxter Bioscience Device Description The DUPLOREACH Extended Applicato… | 1999 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K071126 | Cryoseal FS Applicator System | 2007 | 0 |
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 5 years and passes through 2 companies; a new generation was cleared every 2.7 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K071126 (Thermogenesis Corp., 2007) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K992351.
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 DUPLOREACH Extended Applicator, in conjunction with the DUPLOJECT Double-Barreled Syringe Applicator Device, is intended for the mixing and delivery of TISSEEL VH Fibrin Sealant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K014088 · printed Nov 5, 2026
Cite this page
510(k) Report. “K014088: Duploreach.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K014088
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026