510(k) · Cleared
Recalled · Class III · 2024NavaClick Injection System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lineage Biomedical, Inc. · FMF Syringe, Piston
Cleared on Nov 30, 2023 as substantially equivalent to K171362 (Merit Medical Systems, Inc., 2017) after a 157-day review. Its family tree reaches back 3 generations to 1998. It has been recalled once.
- Decided
- Nov 30, 2023
- Review
- 157 days
- Class
- Class II
- Product code
- FMF
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 3 generations to K980987 (1998). No later device cites it as a predicate yet.
- Root · 3 generations backK980987 Becton Dickinson SyringeBd Becton Dickinson Vacutainer Systems Preanalytic · 1998 · Recalled
- 2 generations backK110771 BD Single Use, Hypodermic SyringeBecton, Dickinson and Company · 2011 · Recalled
- 1 generation backK171362 Merit SyringeMerit Medical Systems, Inc. · 2017
- This deviceK231877 NavaClick Injection SystemLineage Biomedical, Inc. · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K980987 | Becton Dickinson Syringe | Bd Becton Dickinson Vacutainer Systems Preanalytic | 1998 | 15 |
| −2 | K110771 | BD Single Use, Hypodermic Syringe | Becton, Dickinson and Company | 2011 | 10 |
| −1 | K171362 | Merit Syringe | Merit Medical Systems, Inc. | 2017 | — |
| 0 (this device) | K231877 | NavaClick Injection System | Lineage Biomedical, Inc. | 2023 | — |
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 |
|---|---|---|---|
| * | K171362 | Merit SyringeSummary page 4…N NAME: Piston Syringe CLASSIFICATION REG/PANEL: 21 CFR 880.5860/ General and Plastic Surgery PROCODE: FMF PREDICATE DEVICE: Merit Syringe K171362 DEVICE DESCRIPTION: The NavaClick Injector is a manually-operated, 1 mL piston syringe consisting of a calibrated, hollow barre… | 2017 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 12, 2024 | Class III | Z-2535-2024 | Error in labeling | Incorrect GTIN number on carton. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 25 years and passes through 4 companies; a new generation was cleared every 6.3 years on median.
- 2 of the 3 ancestors have a recall of any class.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 NavaClick Injection System is intended for injection of fluids into the body. It is specifically indicated for injection of botulinum neurotoxin, consistent with the neurotoxin’s approved labeling.
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/K231877 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231877: NavaClick Injection System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231877
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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