510(k) · Cleared
ClearedGuide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Maquet Critical Care AB · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Dec 11, 2015 as substantially equivalent to K101199 (Maquet Critical Care AB, 2010) after a 10-day review. Its family tree reaches back 3 generations to 1983.
- Decided
- Dec 11, 2015
- Review
- 10 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K831840 (1983). 5 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK831840 Feeding Tube Placement StyletBiosearch Medical Products, Inc. · 1983
- 2 generations backK960632 Kangaroo Feeding Tube Placment StyletSherwood Medical Co. · 1996
- 1 generation backK101199 Guide Wire for Edi Catheter, 8FR,125CM,5 Each,Guide Wire for Edi…Maquet Critical Care AB · 2010
- This deviceK153461 Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr…Maquet Critical Care AB · 2015
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K831840 | Feeding Tube Placement Stylet | Biosearch Medical Products, Inc. | 1983 | — |
| −2 | K960632 | Kangaroo Feeding Tube Placment Stylet | Sherwood Medical Co. | 1996 | — |
| −1 | K101199 | Guide Wire for Edi Catheter, 8FR,125CM,5 Each,Guide Wire for Edi Catheter… | Maquet Critical Care AB | 2010 | — |
| 0 (this device) | K153461 | Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm… | Maquet Critical Care AB | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1989 | 1 | 0 |
| 1992 | 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 KNT? 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 KNT device
- #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 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 |
|---|---|---|---|
| * | K101199 | Guide Wire for Edi Catheter, 8FR,125CM,5 Each,Guide Wire for Edi Catheter, 8FR,125CM,5…Summary page 5…Legally marketed devices to which equivalence is being claimed 510(k) # Guide wire for Edi Catheter K101199 Indication for use: The guide wire is intended to be used as a stylet inserted into the Maquet Edi Catheter to stiffen it in or… | 2010 |
What descends from it?
No later submission names this one as a predicate yet.
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 32 years and passes through 3 companies; a new generation was cleared every 12.7 years on median.
- None of the 5 ancestors has a recall.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, this device’s year, is highlighted.
FDA decisions per year · KNT
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · KNT
136in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · KNT
13in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · KNT
1,451in 2025
MAUDE reports naming product code KNT, 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 | 10 | 118 | 1 | 300 |
| 2008 | 10 | 115 | 82 | 867 |
| 2009 | 11 | 102 | 9 | 818 |
| 2010 | 12 | 104 | 3 | 517 |
| 2011 | 7 | 211 | 2 | 531 |
| 2012 | 12 | 107 | 1 | 528 |
| 2013 | 7 | 128 | 0 | 747 |
| 2014 | 16 | 259 | 0 | 1,030 |
| 2015 | 10 | 140 | 1 | 1,048 |
| 2016 | 6 | 99 | 3 | 1,251 |
| 2017 | 9 | 247 | 4 | 1,672 |
| 2018 | 7 | 149 | 2 | 1,901 |
| 2019 | 10 | 126 | 2 | 1,838 |
| 2020 | 5 | 102 | 1 | 1,641 |
| 2021 | 6 | 121 | 2 | 1,655 |
| 2022 | 7 | 110 | 1 (1) | 1,650 |
| 2023 | 5 | 162 | 2 | 1,863 |
| 2024 | 9 | 103 | 0 | 1,344 |
| 2025 | 4 | 136 | 13 | 1,451 |
| 2026 | 3 | 105 | 20 | — |
What is it indicated for?
The guide wire is intended to be used as a stylet inserted into the MAQUET Edi Catheter to stiffen it in order to simplify its placement in the intended patient population comprising adult, pediatric, infant and neonatal patients.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K153461 · printed Nov 6, 2026
Cite this page
510(k) Report. “K153461: Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire for Edi Catheter 8 Fr, 125 cm.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K153461
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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