510(k) · Cleared
ClearedDuoflo Dispenser
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Hemaedics, Inc. · FMF Syringe, Piston
Cleared on Dec 29, 1987 after a 183-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 9 later devices descend from it.
- Decided
- Dec 29, 1987
- Review
- 183 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 0
9 later devices descend from it, 2 citing it directly.
- This deviceK872565 Duoflo DispenserHemaedics, Inc. · 1987
- Descendant · cites it directly · 8 of its ownK964833 Rmi Dual Fluid Irrigating SyringeResearch Medical, Inc. · 1997
- Descendant · cites it directly · 7 of its ownK973510 Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Immuno-U.S., Inc. · 1997
- Descendant · 2 generations on · 3 of its ownK981089 Tissomat and Spray SetBaxter Healthcare Corp · 2000
- Descendant · 2 generations on · 1 of its ownK020666 Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp · 2002 · Recalled
- Descendant · 3 generations on · 0 of its ownK071126 Cryoseal FS Applicator SystemThermogenesis Corp. · 2007
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K964833Rmi Dual Fluid Irrigating SyringeResearch Medical, Inc. · 1997 · cites it directly8descendants
- K973510Duploject (0.5/1.0 ML, 2.0 ML, 5.0 ML)Immuno-U.S., Inc. · 1997 · cites it directly7descendants
- K981089Tissomat and Spray SetBaxter Healthcare Corp · 2000 · 2 generations on3descendants
- K020666Duploject Easy-Prep System 1ML, 2ML, 5MLBaxter Healthcare Corp · 2002 · 2 generations on1descendant
- K071126Cryoseal FS Applicator SystemThermogenesis Corp. · 2007 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K872565 | Duoflo Dispenser | Hemaedics, Inc. | 1987 | — |
| +1 | 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 | — |
| +2 | K981089 | Tissomat and Spray Set | Baxter Healthcare Corp | 2000 | — |
| +2 | K020666 | Duploject Easy-Prep System 1ML, 2ML, 5ML | Baxter Healthcare Corp | 2002 | 1 |
| +3 | K071126 | Cryoseal FS Applicator System | Thermogenesis Corp. | 2007 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 2 | 0 |
| 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), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (9)
2 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?
- Of its descendants, K964833 (Research Medical, Inc., 1997) has gone furthest, with 8 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) | — |
https://510kreport.com/device/K872565 · printed Nov 4, 2026
Cite this page
510(k) Report. “K872565: Duoflo Dispenser.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K872565
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026