510(k) · Cleared
ClearedInstylla Delivery Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Instylla, Inc. · FMF Syringe, Piston
Cleared on Dec 22, 2025 as substantially equivalent to K213632 (Instylla, Inc., 2022) after a 27-day review. Its family tree reaches back 6 generations to 1988. 2 of the 8 devices in its family, counting itself, have a Class I recall.
- Decided
- Dec 22, 2025
- Review
- 27 days
- Class
- Class II
- Product code
- FMF
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K873955 (1988). 7 ancestors in all. No later device cites it as a predicate yet. 2 of the 8 devices in this family, counting this one, have a Class I recall.
- Root · 6 generations backK873955 Namic Angiographic SyringeNorth American Instrument Corp. · 1988 · Recalled (Class I)
- 5 generations backK113198 Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 MLNavilyst Medical, Inc. · 2011 · Recalled (Class I)
- 4 generations backK140194 Namic RCS SyringeNavilyst Medical, Inc. · 2014
- 3 generations backK191659 Instylla Delivery KitInstylla, Inc. · 2019
- 2 generations backK202544 Instylla Delivery KitInstylla, Inc. · 2021
- 1 generation backK213632 Instylla Delivery KitInstylla, Inc. · 2022
- This deviceK253769 Instylla Delivery KitInstylla, Inc. · 2025
Class I recalls in this family
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K873955 | Namic Angiographic Syringe | North American Instrument Corp. | 1988 | Class I |
| −5 | K113198 | Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 ML | Navilyst Medical, Inc. | 2011 | Class I |
| −4 | K140194 | Namic RCS Syringe | Navilyst Medical, Inc. | 2014 | — |
| −3 | K191659 | Instylla Delivery Kit | Instylla, Inc. | 2019 | — |
| −2 | K202544 | Instylla Delivery Kit | Instylla, Inc. | 2021 | — |
| −1 | K213632 | Instylla Delivery Kit | Instylla, Inc. | 2022 | — |
| 0 (this device) | K253769 | Instylla Delivery Kit | Instylla, Inc. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 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.
2 devices in this family have a Class I recall. 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? (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 |
|---|---|---|---|
| * | K213632 | Instylla Delivery KitSummary page 5…edicate Device: Proprietary Name: Instylla Delivery Kit Manufacturer: Instylla. Inc. 510(k) Number: K213632 Device Description: The Instylla Delivery Kit is comprised of two delivery syringes, a syringe holder, and a plunger clip (link)… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (2 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K113198Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 MLNavilyst Medical, Inc. · 2011 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
- K873955Namic Angiographic SyringeNorth American Instrument Corp. · 1988 · 4 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 37 years and passes through 3 companies; a new generation was cleared every 3.9 years on median.
- 2 of the 7 ancestors have a recall of any class; 2 have a Class I recall.
How does its category compare?
All FMF devicesFMF Syringe, Piston: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Instylla Delivery Kit is intended to be used for the intra-arterial or intra-venous administration of radiographic
contrast media, saline, and other aqueous solutions.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K253769 · printed Nov 4, 2026
Cite this page
510(k) Report. “K253769: Instylla Delivery Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K253769
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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