510(k) · Cleared
ClearedPedi-Tube (R) Stylet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosearch Medical Products, Inc. · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Oct 3, 1989 after a 64-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 3 later devices descend from it.
- Decided
- Oct 3, 1989
- Review
- 64 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK894857 Pedi-Tube (R) StyletBiosearch Medical Products, Inc. · 1989
- Descendant · cites it directly · 2 of its ownK960632 Kangaroo Feeding Tube Placment StyletSherwood Medical Co. · 1996
- Descendant · cites it directly · 1 of its ownK101199 Guide Wire for Edi Catheter, 8FR,125CM,5 Each,Guide Wire for Edi…Maquet Critical Care AB · 2010
- Descendant · 2 generations on · 0 of its ownK153461 Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr…Maquet Critical Care AB · 2015
Most influential descendants
Showing 3 of 3 · See all- K960632Kangaroo Feeding Tube Placment StyletSherwood Medical Co. · 1996 · cites it directly2descendants
- K101199Guide Wire for Edi Catheter, 8FR,125CM,5 Each,Guide Wire for Edi Catheter, 8FR,125CM,5…Maquet Critical Care AB · 2010 · cites it directly1descendant
- K153461Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm, Guide wire…Maquet Critical Care AB · 2015 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K894857 | Pedi-Tube (R) Stylet | Biosearch Medical Products, Inc. | 1989 | — |
| +1 | 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 | — |
| +2 | K153461 | Guide wire for Edi Catheter 6 Fr, Guide wire for Edi Catheter 8 Fr, 100 cm… | Maquet Critical Care AB | 2015 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 1 | 0 |
| 2010 | 1 | 0 |
| 2015 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (3)
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?
- Of its descendants, K960632 (Sherwood Medical Co., 1996) has gone furthest, with 2 descendants of its own.
How does its category compare?
All KNT devicesKNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.
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 | — |
https://510kreport.com/device/K894857 · printed Nov 4, 2026
Cite this page
510(k) Report. “K894857: Pedi-Tube (R) Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K894857
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026