510(k) · Cleared
ClearedMiniLoad Syringe
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Ocuject, LLC · FMF Syringe, Piston
Cleared on Feb 19, 2021 as substantially equivalent to K101547 (Henke-Sass, Wolf GmbH, 2010) after a 178-day review. Its family tree reaches back 5 generations to 1994. 2 later devices descend from it.
- Decided
- Feb 19, 2021
- Review
- 178 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K944355 (1994). 6 ancestors in all, the oldest K821537 (1982). 2 later devices descend from it, 2 citing it directly.
- Root · 5 generations backK944355 Nipro Branded Disposable Syringes, NeedlesNissho Corp. · 1994
- 4 generations backK030683 Nipro Disposable SyringesNipro Medical Corp. · 2003
- 3 generations backK051574 Nipro Disposable Syringe with or Without NeedleNipro Medical Corp. · 2005
- 2 generations backK063280 Injekt SyringeB.Braun Medical, Inc. · 2006 · Recalled
- 1 generation backK101547 Henke- Sass, Wolf Piston Syringe (Norm-Jet)Henke-Sass, Wolf GmbH · 2010
- This deviceK202432 MiniLoad SyringeOcuject, LLC · 2021
- Descendant · cites it directly · 0 of its ownK231558 SMB Luer lock disposable syringeSmb Corporation of India · 2024
- Descendant · cites it directly · 0 of its ownK212544 MiniLoad SyringeOcuject, LLC · 2021
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K944355 | Nipro Branded Disposable Syringes, Needles | Nissho Corp. | 1994 | — |
| −4 | K030683 | Nipro Disposable Syringes | Nipro Medical Corp. | 2003 | — |
| −3 | K051574 | Nipro Disposable Syringe with or Without Needle | Nipro Medical Corp. | 2005 | — |
| −2 | K063280 | Injekt Syringe | B.Braun Medical, Inc. | 2006 | 2 |
| −1 | K101547 | Henke- Sass, Wolf Piston Syringe (Norm-Jet) | Henke-Sass, Wolf GmbH | 2010 | — |
| 0 (this device) | K202432 | MiniLoad Syringe | Ocuject, LLC | 2021 | — |
| +1 | K231558 | SMB Luer lock disposable syringe | Smb Corporation of India | 2024 | — |
| +1 | 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 | 1 | 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? (1)
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 |
|---|---|---|---|
| * | K101547 | Henke- Sass, Wolf Piston Syringe (Norm-Jet)Summary page 4…Regulatory Class: II Product Code: FMF Regulation: 21 CFR 880.5860 III. PREDICATE DEVICE NORM-JECT Syringe (K101547)- primary predicate This predicate has not been subject to a design-related recall IV. DEVICE DESCR… | 2010 |
What descends from it? (2)
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?
- The line of descent spans 27 years and passes through 5 companies; a new generation was cleared every 4.0 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K231558 (Smb Corporation of India, 2024) has gone furthest, with 0 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. 2021, 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 MiniLoad Syringe is used to facilitate injections into or withdraw fluids from the body.
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/K202432 · printed Nov 6, 2026
Cite this page
510(k) Report. “K202432: MiniLoad Syringe.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K202432
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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