510(k) · Cleared
ClearedAN-10S Andersen Tube with Stylet
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
H.W. Andersen Products, Inc. · BSS Tube, Nasogastric
Cleared on Dec 30, 1994 after a 396-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 2 later devices descend from it.
- Decided
- Dec 30, 1994
- Review
- 396 days
- Class
- Class II
- Product code
- BSS
- Recalls
- None
- Predicates
- 0
2 later devices descend from it, 2 citing it directly.
- This deviceK935688 AN-10S Andersen Tube with StyletH.W. Andersen Products, Inc. · 1994
- Descendant · cites it directly · 0 of its ownK021493 Andersen Nasogastric Tube with Stylet, Models an 11S, 13S, 14S & 18SAndersen Products, Inc. · 2002
- Descendant · cites it directly · 0 of its ownK961711 Aspisafe Gastric TubeB.Braun Medical, Inc. · 1997
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) | K935688 | AN-10S Andersen Tube with Stylet | H.W. Andersen Products, Inc. | 1994 | — |
| +1 | K021493 | Andersen Nasogastric Tube with Stylet, Models an 11S, 13S, 14S & 18S | Andersen Products, Inc. | 2002 | — |
| +1 | K961711 | Aspisafe Gastric Tube | B.Braun Medical, Inc. | 1997 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2002 | 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 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 has not posted a summary or statement for it, so its predicates are not known.
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, K021493 (Andersen Products, Inc., 2002) 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 | — |
https://510kreport.com/device/K935688 · printed Nov 6, 2026
Cite this page
510(k) Report. “K935688: AN-10S Andersen Tube with Stylet.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K935688
Report an extraction error
Are you the manufacturer?
Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026