510(k) · Cleared
Recalled · Class II · 2023Henke Disposable Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
C. B. Dumont Company, Inc. · FMF Syringe, Piston
Cleared on May 28, 1982 after a 4-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it. It has been recalled once.
- Decided
- May 28, 1982
- Review
- 4 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 0
4 later devices descend from it, 1 citing it directly.
- This deviceK821537 Henke Disposable SyringeC. B. Dumont Company, Inc. · 1982
- Descendant · cites it directly · 3 of its ownK101547 Henke- Sass, Wolf Piston Syringe (Norm-Jet)Henke-Sass, Wolf GmbH · 2010
- Descendant · 2 generations on · 2 of its ownK202432 MiniLoad SyringeOcuject, LLC · 2021
- Descendant · 3 generations on · 0 of its ownK231558 SMB Luer lock disposable syringeSmb Corporation of India · 2024
- Descendant · 3 generations on · 0 of its ownK212544 MiniLoad SyringeOcuject, LLC · 2021
Most influential descendants
Showing 4 of 4 · See all- K101547Henke- Sass, Wolf Piston Syringe (Norm-Jet)Henke-Sass, Wolf GmbH · 2010 · cites it directly3descendants
- K202432MiniLoad SyringeOcuject, LLC · 2021 · 2 generations on2descendants
- K231558SMB Luer lock disposable syringeSmb Corporation of India · 2024 · 3 generations on0descendants
- K212544MiniLoad SyringeOcuject, LLC · 2021 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K821537 | Henke Disposable Syringe | C. B. Dumont Company, Inc. | 1982 | — |
| +1 | K101547 | Henke- Sass, Wolf Piston Syringe (Norm-Jet) | Henke-Sass, Wolf GmbH | 2010 | — |
| +2 | K202432 | MiniLoad Syringe | Ocuject, LLC | 2021 | — |
| +3 | K231558 | SMB Luer lock disposable syringe | Smb Corporation of India | 2024 | — |
| +3 | K212544 | MiniLoad Syringe | Ocuject, LLC | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2021 | 2 | 0 |
| 2024 | 1 | 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 16.1 · 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K101547 | Henke- Sass, Wolf Piston Syringe (Norm-Jet) | 2010 | 3 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 27, 2023 | Class II | Z-2642-2023 | Under Investigation by firm | Sterile barrier might be damaged compromising the sterility of the device. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K101547 (Henke-Sass, Wolf GmbH, 2010) has gone furthest, with 3 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/K821537 · printed Nov 6, 2026
Cite this page
510(k) Report. “K821537: Henke Disposable Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K821537
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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