510(k) · Cleared
Recalled · Class I · 2026Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 ML
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Navilyst Medical, Inc. · DXT Injector And Syringe, Angiographic
Cleared on Nov 28, 2011 as substantially equivalent to K873955 (North American Instrument Corp., 1988) after a 28-day review. Its family tree reaches back 1 generation to 1988. 2 of the 9 devices in its family, counting itself, have a Class I recall. 7 later devices descend from it. It has been recalled once, including a Class I recall.
- Decided
- Nov 28, 2011
- Review
- 28 days
- Class
- Class II
- Product code
- DXT
- Recalls
- 1 (1 Class I)
- Predicates
- 1
Its longest line of descent runs back 1 generation to K873955 (1988). 7 later devices descend from it, 2 citing it directly. 2 of the 9 devices in this family, counting this one, have a Class I recall.
- Root · 1 generation backK873955 Namic Angiographic SyringeNorth American Instrument Corp. · 1988 · Recalled (Class I)
- This deviceK113198 Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 MLNavilyst Medical, Inc. · 2011
- Descendant · cites it directly · 4 of its ownK140194 Namic RCS SyringeNavilyst Medical, Inc. · 2014
- Descendant · 2 generations on · 3 of its ownK191659 Instylla Delivery KitInstylla, Inc. · 2019
- Descendant · 3 generations on · 2 of its ownK202544 Instylla Delivery KitInstylla, Inc. · 2021
- Descendant · 3 generations on · 1 of its ownK213632 Instylla Delivery KitInstylla, Inc. · 2022
- Descendant · cites it directly · 1 of its ownK163084 Merit Coronary Control SyringeMerit Medical Systems, Inc. · 2017
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K873955 Namic Angiographic Syringedirect predicate · 1988
Most influential descendants
Showing 5 of 7 · See all- K140194Namic RCS SyringeNavilyst Medical, Inc. · 2014 · cites it directly4descendants
- K191659Instylla Delivery KitInstylla, Inc. · 2019 · 2 generations on3descendants
- K202544Instylla Delivery KitInstylla, Inc. · 2021 · 3 generations on2descendants
- K213632Instylla Delivery KitInstylla, Inc. · 2022 · 3 generations on1descendant
- K163084Merit Coronary Control SyringeMerit Medical Systems, Inc. · 2017 · cites it directly1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K873955 | Namic Angiographic Syringe | North American Instrument Corp. | 1988 | Class I |
| 0 (this device) | K113198 | Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 ML | Navilyst Medical, Inc. | 2011 | — |
| +1 | K140194 | Namic RCS Syringe | Navilyst Medical, Inc. | 2014 | — |
| +2 | K191659 | Instylla Delivery Kit | Instylla, Inc. | 2019 | — |
| +3 | K202544 | Instylla Delivery Kit | Instylla, Inc. | 2021 | — |
| +3 | K213632 | Instylla Delivery Kit | Instylla, Inc. | 2022 | — |
| +1 | K163084 | Merit Coronary Control Syringe | Merit Medical Systems, Inc. | 2017 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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 DXT device
- #1 K253048 High Pressure Syringe; Pressure Connecting…score 13.6 · 9 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 |
|---|---|---|---|
| * | K873955 | Namic Angiographic SyringeSummary page 4…ntrol Syringe Piston Syringe 21 CFR §880.5860, Class Il General Hospital NAMIC Angiographic Control Syringe Control Syringe Piston Syringe 21 CFR §880.5860, Class 1} K873955 The NMI Control Syringes are manual control, piston type syringes consisting of a clear, calibrated, hollow barrel accommodating… | 1988 |
What descends from it? (7)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (2 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Feb 27, 2026 | Class I | Z-1713-2026 | Under Investigation by firm | Medline Industries, LP has identified through post-market surveillance a potential risk of the syringe rotating adaptor unwinding during use, which may result in a loose connection and/or full disconnection between the syringe and manifold. |
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.
- K873955Namic Angiographic SyringeNorth American Instrument Corp. · 1988 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
How does its category compare?
All DXT devicesDXT Injector And Syringe, Angiographic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DXT
1in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXT
138in 2024
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXT
10in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXT
97in 2025
MAUDE reports naming product code DXT, 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 | 3 | 182 | 4 | 107 |
| 2008 | 2 | — | 3 | 168 |
| 2009 | 6 | 137 | 7 | 188 |
| 2010 | 1 | — | 3 | 124 |
| 2011 | 4 | 69 | 3 | 133 |
| 2012 | 0 | — | 7 | 135 |
| 2013 | 2 | — | 0 | 141 |
| 2014 | 6 | 144 | 0 | 97 |
| 2015 | 7 | 153 | 1 | 135 |
| 2016 | 8 | 172 | 0 | 152 |
| 2017 | 7 | 183 | 0 | 128 |
| 2018 | 9 | 93 | 2 | 129 |
| 2019 | 4 | 96 | 0 | 121 |
| 2020 | 3 | 154 | 1 | 93 |
| 2021 | 1 | — | 1 | 132 |
| 2022 | 0 | — | 0 | 111 |
| 2023 | 1 | — | 2 | 117 |
| 2024 | 4 | 138 | 10 | 118 |
| 2025 | 1 | — | 0 | 97 |
| 2026 | 7 | 264 | 6 | — |
What is it indicated for?
The NMI Control Syringe is intended to be used for the intra-arterial or intravenous administration of radiographic contrast media.
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/K113198 · printed Nov 6, 2026
Cite this page
510(k) Report. “K113198: Nmi Control Syringe, 7 ML Nmi Control Syringe, 8 ML.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K113198
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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