510(k) · Cleared
ClearedY2K2 Enternal Tube Fluid Filter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moss Medical Products · KNT Tubes, Gastrointestinal (And Accessories)
Cleared on Nov 2, 2005 as substantially equivalent to K943127 (Gelman Sciences, Inc., 1994) and 1 other predicate after a 175-day review. Its family tree reaches back 1 generation to 1985.
- Decided
- Nov 2, 2005
- Review
- 175 days
- Class
- Class II
- Product code
- KNT
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K850139 (1985). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK850139 Cobe Cop Filter Cardiopulmonary Prebypass FilterRapid Diagnostic Laboratories, Inc. · 1985
- This deviceK051206 Y2K2 Enternal Tube Fluid FilterMoss Medical Products · 2005
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K850139 | Cobe Cop Filter Cardiopulmonary Prebypass Filter | Rapid Diagnostic Laboratories, Inc. | 1985 | — |
| 0 (this device) | K051206 | Y2K2 Enternal Tube Fluid Filter | Moss Medical Products | 2005 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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? (2)
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 |
|---|---|---|---|
| * | K943127 | Pharmassure Large Volume Transfer FiltersSummary page 1…11411 Price Road Hebron, IL 60034-0310 PREDICATE DEVICES: Pall PharmAssure Capsule Filter (K943127) Cobe Cardiovascular Pre-bypass Filter (K850139) INDICATIONS FOR USE: The device w… | 1994 |
| * | K850139 | Cobe Cop Filter Cardiopulmonary Prebypass FilterSummary page 1…EDICATE DEVICES: Pall PharmAssure Capsule Filter (K943127) Cobe Cardiovascular Pre-bypass Filter (K850139) INDICATIONS FOR USE: The device will filter fluids to be delivered into a feeding tube to remove potentially obstructing partic… | 1985 |
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?
- None of the 2 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.
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 Y2K2 Enteral In-Line Filter is intended for use to filter liquid feeding solutions prior to delivery into a patients pre-inserted feeding tube, to minimize the risk of tube occlusion by macro particulates.
This will be applicable to any size or length pediatric or adult feeding tube (e.g., nasogastric, nasoduodenal, nasojejunal, gastrostomy, jejunostomy, transgastric duodenal, or transgastric jejunal).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K051206 · printed Nov 5, 2026
Cite this page
510(k) Report. “K051206: Y2K2 Enternal Tube Fluid Filter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K051206
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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