510(k) · Cleared
ClearedDuploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Immuno-U.S., Inc. · FMF Syringe, Piston
Cleared on Dec 8, 1997 as substantially equivalent to K872565 (Hemaedics, Inc., 1987) and 2 other predicates after an 83-day review. Its family tree reaches back 2 generations to 1987. 7 later devices descend from it.
- Decided
- Dec 8, 1997
- Review
- 83 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 2 generations to K872565 (1987). 3 ancestors in all. 7 later devices descend from it, 4 citing it directly.
- Root · 2 generations backK872565 Duoflo DispenserHemaedics, Inc. · 1987
- 1 generation backK964833 Rmi Dual Fluid Irrigating SyringeResearch Medical, Inc. · 1997
- This deviceK973510 Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Immuno-U.S., Inc. · 1997
- Descendant · cites it directly · 3 of its ownK981089 Tissomat and Spray SetBaxter Healthcare Corp · 2000
- Descendant · cites it directly · 1 of its ownK020666 Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp · 2002 · Recalled
- Descendant · 2 generations on · 0 of its ownK071126 Cryoseal FS Applicator SystemThermogenesis Corp. · 2007
- Descendant · cites it directly · 0 of its ownK063535 Caption ApplicatorSmith & Nephew, Inc. · 2007
- Descendant · 2 generations on · 0 of its ownK050495 Easyspray and Spray Set for Tisseel (Fiber Sealant)Baxter Healthcare Corp., Bioscience · 2005
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K981089Tissomat and Spray SetBaxter Healthcare Corp · 2000 · cites it directly3descendants
- K020666Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp · 2002 · cites it directly1descendant
- K071126Cryoseal FS Applicator SystemThermogenesis Corp. · 2007 · 2 generations on0descendants
- K063535Caption ApplicatorSmith & Nephew, Inc. · 2007 · cites it directly0descendants
- K050495Easyspray and Spray Set for Tisseel (Fiber Sealant)Baxter Healthcare Corp., Bioscience · 2005 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K872565 | Duoflo Dispenser | Hemaedics, Inc. | 1987 | — |
| −1 | K964833 | Rmi Dual Fluid Irrigating Syringe | Research Medical, Inc. | 1997 | — |
| 0 (this device) | K973510 | Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML) | Immuno-U.S., Inc. | 1997 | — |
| +1 | K981089 | Tissomat and Spray Set | Baxter Healthcare Corp | 2000 | — |
| +1 | K020666 | Duploject Easy-Prep System 1ML, 2ML, 5ML | Baxter Healthcare Corp | 2002 | 1 |
| +2 | K071126 | Cryoseal FS Applicator System | Thermogenesis Corp. | 2007 | — |
| +1 | K063535 | Caption Applicator | Smith & Nephew, Inc. | 2007 | — |
| +2 | K050495 | Easyspray and Spray Set for Tisseel (Fiber Sealant) | Baxter Healthcare Corp., Bioscience | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1988 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 1 | 0 |
| 2007 | 2 | 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 16.2 · 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 |
|---|---|---|---|
| * | K872565 | Duoflo DispenserSummary page 1…248-608-3202 Fax: 248-652-0670 Date summary was prepared Spetember 16, 1997 Name(s) of the device Duploject® Identification of predicate device(s) Duoflo Dispenser K872565 Manufactured by Hemaedics, Inc. RMI Dual Fluid Irrigating Syringe K964833 Manufactured by Research Medical, Inc. Surgical Seala… | 1987 |
| * | K964833 | Rmi Dual Fluid Irrigating SyringeSummary page 1…97 Name(s) of the device Duploject® Identification of predicate device(s) Duoflo Dispenser K872565 Manufactured by Hemaedics, Inc. RMI Dual Fluid Irrigating Syringe K964833 Manufactured by Research Medical, Inc. Surgical Sealant Dispenser (SSD) K881020 Micromedics, Inc. Description of the device K… | 1997 |
| * | K881020 | Surgical Sealant Dispenser (SSD)Summary page 1…lo Dispenser K872565 Manufactured by Hemaedics, Inc. RMI Dual Fluid Irrigating Syringe K964833 Manufactured by Research Medical, Inc. Surgical Sealant Dispenser (SSD) K881020 Micromedics, Inc. Description of the device Ka13slo OEC - 8 1997 The Duploject® is a single-use, disposable syringe, which i… | 1988 |
What descends from it? (7)
4 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 10 years and passes through 3 companies; a new generation was cleared every 9.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- Of its descendants, K981089 (Baxter Healthcare Corp, 2000) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K872565.
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® is intended for use in the simuitaneous delivery of two non-homogenous fluids or solutions onto a surgical site. The Duploject® is equipped with a syringe holder, which assures controlled, accurate dispensing, and a needle holder, which allows the contents of the syringes to mix prior to dispensing.
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/K973510 · printed Nov 4, 2026
Cite this page
510(k) Report. “K973510: Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K973510
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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