510(k) · Cleared
ClearedTurboSEAL Nasogastric Aspiration Tube
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Turboseal, L.P. · BSS Tube, Nasogastric
Cleared on Dec 19, 2014 as substantially equivalent to K984629 (Moss Tubes, Inc., 1999) and 1 other predicate after a 106-day review. Its family tree reaches back 1 generation to 1996.
- Decided
- Dec 19, 2014
- Review
- 106 days
- Class
- Class II
- Product code
- BSS
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K960176 (1996). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK960176 Davol Nasogastric Sump Tube W/Prevent FilterC.R. Bard, Inc. · 1996 · Recalled
- This deviceK142483 TurboSEAL Nasogastric Aspiration TubeTurboseal, L.P. · 2014
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K960176 | Davol Nasogastric Sump Tube W/Prevent Filter | C.R. Bard, Inc. | 1996 | 17 |
| 0 (this device) | K142483 | TurboSEAL Nasogastric Aspiration Tube | Turboseal, L.P. | 2014 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 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 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? (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 |
|---|---|---|---|
| * | K984629 | Moss Tubes, Inc. Nasal Tube - Mark IVSummary page 5…Devices: The TurboSEAL™ NGAT is claimed to be substantially equivalent to the following legally marketed predicate device: • Moss Tubes, Inc. Nasal Tube – Mark IV (K984629) • Davol® Nasogastric Sump Tube with PreVent™ Anti-Reflux Filter, Davol Inc. (a Bard Company) (K960176) === Page 6 =… | 1999 |
| * | K960176 | Davol Nasogastric Sump Tube W/Prevent FilterSummary page 5…device: • Moss Tubes, Inc. Nasal Tube – Mark IV (K984629) • Davol® Nasogastric Sump Tube with PreVent™ Anti-Reflux Filter, Davol Inc. (a Bard Company) (K960176) K142483… | 1996 |
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?
- 1 of the 2 ancestors has a recall of any class.
- 1 other device also cites its predicate K984629.
How does its category compare?
All BSS devicesBSS Tube, Nasogastric: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
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?
The TurboSEAL™ Nasogastric Aspiration Tube (NGAT) is intended for gastric decompression, gastric lavage and the administration of nutritional supplements through the distal tube port. It is also indicated for the aspiration of small quantities of refluxed gastric fluid from the distal esophageal aspiration areas.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K142483 · printed Nov 5, 2026
Cite this page
510(k) Report. “K142483: TurboSEAL Nasogastric Aspiration Tube.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K142483
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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