510(k) · Cleared
ClearedEnteral Feeding Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biosearch Medical Products, Inc. · BSS Tube, Nasogastric
Cleared on Oct 12, 2005 after a 131-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Oct 12, 2005
- Review
- 131 days
- Class
- Class II
- Product code
- BSS
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in BSS? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All BSS devicesBSS Tube, Nasogastric: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · BSS
1in 2014
2026 to Oct 25, outlined.
Median 510(k) review, days · BSS
Too few BSS 510(k)s in any year since 2007 to give a median.
Recalls per year · BSS
5in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · BSS
10in 2025
MAUDE reports naming product code BSS, 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 | 0 | — | 0 | 1 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 2 |
| 2011 | 0 | — | 0 | 2 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 4 |
| 2016 | 0 | — | 0 | 1 |
| 2017 | 0 | — | 0 | 9 |
| 2018 | 0 | — | 0 | 9 |
| 2019 | 0 | — | 0 | 14 |
| 2020 | 0 | — | 0 | 6 |
| 2021 | 0 | — | 0 | 8 |
| 2022 | 0 | — | 0 | 22 |
| 2023 | 0 | — | 5 | 27 |
| 2024 | 0 | — | 0 | 14 |
| 2025 | 0 | — | 0 | 10 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
Indications for use would be when the patient cannot feed him/herself and cannot be fed by another person. This catheter would be placed Nasogastrically and nutrients supplied through catheter to the patient.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K051480 · printed Nov 6, 2026
Cite this page
510(k) Report. “K051480: Enteral Feeding Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K051480
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026