510(k) · Cleared
ClearedHenke- Sass, Wolf Piston Syringe (Norm-Jet)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Henke-Sass, Wolf GmbH · FMF Syringe, Piston
Cleared on Nov 22, 2010 as substantially equivalent to K821537 (C. B. Dumont Company, Inc., 1982) and 1 other predicate after a 172-day review. Its family tree reaches back 4 generations to 1994. 3 later devices descend from it.
- Decided
- Nov 22, 2010
- Review
- 172 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K944355 (1994). 5 ancestors in all, the oldest K821537 (1982). 3 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
- 3 generations backK030683 Nipro Disposable SyringesNipro Medical Corp. · 2003
- 2 generations backK051574 Nipro Disposable Syringe with or Without NeedleNipro Medical Corp. · 2005
- 1 generation backK063280 Injekt SyringeB.Braun Medical, Inc. · 2006 · Recalled
- This deviceK101547 Henke- Sass, Wolf Piston Syringe (Norm-Jet)Henke-Sass, Wolf GmbH · 2010
- Descendant · cites it directly · 2 of its ownK202432 MiniLoad SyringeOcuject, LLC · 2021
- Descendant · 2 generations on · 0 of its ownK231558 SMB Luer lock disposable syringeSmb Corporation of India · 2024
- Descendant · 2 generations on · 0 of its ownK212544 MiniLoad SyringeOcuject, LLC · 2021
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K944355 | Nipro Branded Disposable Syringes, Needles | Nissho Corp. | 1994 | — |
| −3 | K030683 | Nipro Disposable Syringes | Nipro Medical Corp. | 2003 | — |
| −2 | K051574 | Nipro Disposable Syringe with or Without Needle | Nipro Medical Corp. | 2005 | — |
| −1 | K063280 | Injekt Syringe | B.Braun Medical, Inc. | 2006 | 2 |
| 0 (this device) | K101547 | Henke- Sass, Wolf Piston Syringe (Norm-Jet) | Henke-Sass, Wolf GmbH | 2010 | — |
| +1 | K202432 | MiniLoad Syringe | Ocuject, LLC | 2021 | — |
| +2 | K231558 | SMB Luer lock disposable syringe | Smb Corporation of India | 2024 | — |
| +2 | K212544 | MiniLoad Syringe | Ocuject, LLC | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1982 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 2 | 0 |
| 2024 | 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? (2)
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 |
|---|---|---|---|
| * | K821537 | Henke Disposable SyringeSummary page 2…(onabotulinumtoxinA).” SUBSTANTIAL EQUIVALENCE: The Henke-Sass, Wolf piston syringe is substantially equivalent to the Henke-Sass, Wolf piston syringes under 510(k)# (K821537) and the B.Braun piston syringes under 510(k)# (K063280). (The manufacturing site of B.Braun is also ALMO, Establishment Registra… | 1982 |
| * | K063280 | Injekt SyringeSummary page 2…enke-Sass, Wolf piston syringe is substantially equivalent to the Henke-Sass, Wolf piston syringes under 510(k)# (K821537) and the B.Braun piston syringes under 510(k)# (K063280). (The manufacturing site of B.Braun is also ALMO, Establishment Registration Number: 8010674.) SAFETY AND EFFECTIVENESS INFORMA… | 2006 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K202432 | MiniLoad Syringe | 2021 | 2 |
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 16 years and passes through 4 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K202432 (Ocuject, LLC, 2021) has gone furthest, with 2 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. 2010, this device’s year, is highlighted.
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 HSW NORM-JECT®- syringes are intended to be used to inject into, or withdraw fluids from the body. The 1 ml- syringe with a purple plunger, labeled with BOTOX® is exclusively produced for use with BOTOX® Cosmetic (onabotulinumtoxinA).
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/K101547 · printed Nov 5, 2026
Cite this page
510(k) Report. “K101547: Henke- Sass, Wolf Piston Syringe (Norm-Jet).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101547
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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