510(k) · Cleared
Recalled · 2007Duploject Easy-Prep System 1ML, 2ML, 5ML
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 24, 2002 as substantially equivalent to K973510 (Immuno-U.S., Inc., 1997) and 2 other predicates after a 115-day review. Its family tree reaches back 3 generations to 1987. 1 later device descends from it. It has been recalled once.
- Decided
- Jun 24, 2002
- Review
- 115 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 3
Its longest line of descent runs back 3 generations to K872565 (1987). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 3 generations backK872565 Duoflo DispenserHemaedics, Inc. · 1987
- 2 generations backK964833 Rmi Dual Fluid Irrigating SyringeResearch Medical, Inc. · 1997
- 1 generation backK973510 Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Immuno-U.S., Inc. · 1997
- This deviceK020666 Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter 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 |
|---|---|---|---|---|---|
| −3 | K872565 | Duoflo Dispenser | Hemaedics, Inc. | 1987 | — |
| −2 | K964833 | Rmi Dual Fluid Irrigating Syringe | Research Medical, Inc. | 1997 | — |
| −1 | K973510 | Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML) | Immuno-U.S., Inc. | 1997 | — |
| 0 (this device) | K020666 | Duploject Easy-Prep System 1ML, 2ML, 5ML | Baxter Healthcare Corp | 2002 | — |
| +1 | K071126 | Cryoseal FS Applicator System | Thermogenesis Corp. | 2007 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
| 1997 | 1 | 0 |
| 1999 | 1 | 0 |
| 2000 | 1 | 0 |
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? (3)
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 |
|---|---|---|---|
| * | K973510 | Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Summary page 1…Common/UsuaV Syringe, Piston Classification Name Predicate Devices DUPLOJECT Dual-Barreled Applicator Device 510(k) No. K973510 Baxter Healthcare Corporation, Baxter Bioscience SEALOUETTE Fibrin Sealant… | 1997 |
| * | K992351 | Sealouette Fibrin Sealant ApplicatorSummary page 1…Baxter Healthcare Corporation, Baxter Bioscience SEALOUETTE Fibrin Sealant Applicator 510(k) No. K992351 Baxter Healthcare Corporation, Baxter Bioscience Needleless Transfer Devic… | 1999 |
| * | K001831 | Needleless Transfer Device | 2000 |
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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Oct 25, 2007 | Not classified | Z-0263-2008 | Packaging process control | Sterility (package integrity) compromised: This recall is being conducted due to incomplete seal of the product package at the corner of the outer tray and tyvek lid. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 15 years and passes through 4 companies; a new generation was cleared every 4.5 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K071126 (Thermogenesis Corp., 2007) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K973510.
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 DUPLOJECT EASY-PREP System is indicated for the preparation and application of TISSEEL VH Fibrin Sealant.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K020666 · printed Nov 6, 2026
Cite this page
510(k) Report. “K020666: Duploject Easy-Prep System 1ML, 2ML, 5ML.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K020666
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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