510(k) Report

510(k) · Cleared

Cleared

Andersen Nasogastric Tube with Stylet, Models an 11S, 13S, 14S & 18S

K021493510(k) SpecialCleared Aug 30, 2002113-day reviewClass II21 CFR 876.5980

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Andersen Products, Inc. · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Aug 30, 2002 as substantially equivalent to K935688 (H.W. Andersen Products, Inc., 1994) after a 113-day review. Its family tree reaches back 1 generation to 1994.

Decided
Aug 30, 2002
Review
113 days
Class
Class II
Product code
KNT
Recalls
None
Predicates
1

Its longest line of descent runs back 1 generation to K935688 (1994). No later device cites it as a predicate yet.

K935688 · AN-10S Andersen Tube with Stylet · H.W. Andersen Products, Inc. · 199419901992199419961998200020022004
K935688 · AN-10S Andersen Tube with Stylet · H.W. Andersen Products, Inc. · 19940
  1. Root · 1 generation backK935688 AN-10S Andersen Tube with StyletH.W. Andersen Products, Inc. · 1994
  2. This deviceK021493 Andersen Nasogastric Tube with Stylet, Models an 11S, 13S, 14S & 18SAndersen Products, Inc. · 2002
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−1K935688AN-10S Andersen Tube with StyletH.W. Andersen Products, Inc.1994—
0 (this device)K021493Andersen Nasogastric Tube with Stylet, Models an 11S, 13S, 14S & 18SAndersen Products, Inc.2002—
FIG. 1 — Lineage of K021493, 1994–2002Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
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What was it cleared against? (1)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K935688AN-10S Andersen Tube with Stylet
Summary page 1
…d under Section 5 14 of the Food, Drug and Cosmetic Act for gastrointestinal tubes. Predicate AndersenB Nasogastric Tube with Stylet (AN lOS), K935688 Device Device Sterile, disposable, bilumenal, medical grade vinyl nasogastric tube Description with radiopaque…
H.W. Andersen Products, Inc.1994—

Also cleared against K935688: 1 other device →

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?

  • Its one ancestor has no recall.
  • 1 other device also cites its predicate K935688.

How does its category compare?

All KNT devices

KNT Tubes, Gastrointestinal (And Accessories): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · KNT

4in 2025

2007: 102008: 102009: 112010: 122011: 72012: 122013: 72014: 162015: 102016: 62017: 92018: 72019: 102020: 52021: 62022: 72023: 52024: 92025: 42026 (partial year): 3
2007high 16 (2014) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNT

136in 2025

2007: 118 days median2008: 115 days median2009: 102 days median2010: 104 days median2011: 211 days median2012: 107 days median2013: 128 days median2014: 259 days median2015: 140 days median2016: 99 days median2017: 247 days median2018: 149 days median2019: 126 days median2020: 102 days median2021: 121 days median2022: 110 days median2023: 162 days median2024: 103 days median2025: 136 days median2026 (partial year): 105 days median
2007high 259 (2014) · low 99 (2016)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · KNT

13in 2025

2007: 12008: 822009: 92010: 32011: 22012: 12015: 12016: 32017: 42018: 22019: 22020: 12021: 22022: 1, 1 Class I2023: 22025: 132026 (partial year): 20
2007high 82 (2008) · low 0 (2013)2026

Class I (1 since 2007) Class II/III not classified

Adverse event reports per year · KNT

1,451in 2025

2007: 3002008: 8672009: 8182010: 5172011: 5312012: 5282013: 7472014: 1,0302015: 1,0482016: 1,2512017: 1,6722018: 1,9012019: 1,8382020: 1,6412021: 1,6552022: 1,6502023: 1,8632024: 1,3442025: 1,451
2007high 1,901 (2018) · low 300 (2007)2025

MAUDE reports naming product code KNT, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
2007101181300
20081011582867
2009111029818
2010121043517
201172112531
2012121071528
201371280747
20141625901,030
20151014011,048
201669931,251
2017924741,672
2018714921,901
20191012621,838
2020510211,641
2021612121,655
202271101 (1)1,650
2023516221,863
2024910301,344
20254136131,451
2026310520—

What is it indicated for?

The AndersenB Nasogastric Tube is indicated in those situations where the physician desires to keep the stomach continuously and completely evacuated of swallowed air, swallowed saliva, gastric secretions or fresh blood in a fasting patient for a prolonged period, such as pancreatitis, cholecyctitis, post-operative ileus and non-operative management of peptic ulcer. It is also indicated to keep the stomach evacuated of fresh blood once clots have been removed.

Indications for use as stated in the FDA summary.

Also cleared against K935688

1 other device cites the same predicate.

  • K961711Aspisafe Gastric TubeB.Braun Medical, Inc. · 1997

More from Andersen Products, Inc.

2 FDA decisions under this applicant name. See the company

  • K011077Andersen Intestinal Tube, Miller-Abbott Type (an 22)Andersen Products, Inc. · 2001

Recent decisions in KNT

The KNT category page

  • K262038danumed StomaMeterDanumed Medizintechnik GmbH · 2026
  • K26189052Fr ViSiGi LUX™; 52Fr ViSiGi 3D®Boehringer Laboratories, LLC · 2026
  • K253514Minnesota Four-Lumen Esophagogastric Tamponade Tube - 18 French (0092220); Blakemore Esophageal-Nasogastric…C.R. Bard, Inc. · 2026
  • K250389XNY Disposable Gastric Calibration TubeChangzhou Xin Neng Yuan Medical Stapler Co.,Ltd · 2025
  • K243228Flexi-Seal AIR (with ENFit Connector)Convatec · 2025

https://510kreport.com/device/K021493 · printed Nov 4, 2026

Cite this page

510(k) Report. “K021493: Andersen Nasogastric Tube with Stylet, Models an 11S, 13S, 14S & 18S.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K021493

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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