510(k) · Cleared
ClearedMoss Tubes, Inc. Nasal Tube - Mark IV
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Moss Tubes, Inc. · BSS Tube, Nasogastric
Cleared on Mar 2, 1999 after a 62-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 2 later devices descend from it.
- Decided
- Mar 2, 1999
- Review
- 62 days
- Class
- Class II
- Product code
- BSS
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK984629 Moss Tubes, Inc. Nasal Tube - Mark IVMoss Tubes, Inc. · 1999
- Descendant · cites it directly · 0 of its ownK190414 Moss Gastrostomy Tube, Moss Nasal Tube – Mark IVMoss Tubes, Inc. · 2019
- Descendant · cites it directly · 0 of its ownK142483 TurboSEAL Nasogastric Aspiration TubeTurboseal, L.P. · 2014
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K984629 | Moss Tubes, Inc. Nasal Tube - Mark IV | Moss Tubes, Inc. | 1999 | — |
| +1 | K190414 | Moss Gastrostomy Tube, Moss Nasal Tube – Mark IV | Moss Tubes, Inc. | 2019 | — |
| +1 | K142483 | TurboSEAL Nasogastric Aspiration Tube | Turboseal, L.P. | 2014 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2019 | 1 | 0 |
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? (2)
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, K190414 (Moss Tubes, Inc., 2019) has gone furthest, with 0 descendants of its own.
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?
Used for decompression and simultaneous internal feeding.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K984629 · printed Nov 6, 2026
Cite this page
510(k) Report. “K984629: Moss Tubes, Inc. Nasal Tube - Mark IV.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K984629
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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