510(k) · Cleared

Cleared

Cook Gastric Sizing Balloon Catheter

K030841510(k) TraditionalCleared Jul 11, 2003116-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

Cook, Inc. · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Jul 11, 2003 as substantially equivalent to K002838 (Bioenterics Corp., 2001) after a 116-day review. Its family tree reaches back 1 generation to 2001. 1 later device descends from it.

Decided: Jul 11, 2003
Review: 116 days
Class: Class II
Product code: KNT
Recalls: None
Predicates: 1

Its longest line of descent runs back 1 generation to K002838 (2001). 1 later device descends from it, 1 citing it directly.

By dateBy generation

Root · 1 generation backK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
This deviceK030841 Cook Gastric Sizing Balloon CatheterCook, Inc. · 2003
Descendant · cites it directly · 0 of its ownK173355 Gastric Sizing Balloon CatheterCook Incorporated · 2017

Most influential descendants

Showing 1 of 1 · See all

K173355Gastric Sizing Balloon CatheterCook Incorporated · 2017 · cites it directly0descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K002838	Gastric Suction and Drainage Catheter	Bioenterics Corp.	2001	—
0 (this device)	K030841	Cook Gastric Sizing Balloon Catheter	Cook, Inc.	2003	—
+1	K173355	Gastric Sizing Balloon Catheter	Cook Incorporated	2017	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2017	1	0

FIG. 1 — Lineage of K030841, 2001–2017Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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 K261890 52Fr ViSiGi LUX™; 52Fr ViSiGi 3D®score 12.7 · 4 generations · no Class I recall
#2 Held for the reportin the report
#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.

Type	Number	Device	Applicant	Decided	Recalls
*	K002838	Gastric Suction and Drainage Catheter Summary page 2 …Balloon Catheter is similar to another gastric balloon: the Gastric Balloon Suction Catheter, marketed by BioEnterics, which was found substantially equivalent under DC# K002838. The similar indications for use, materials of construction and the technological characteristics of the Cook Gastric Sizing Bal…	Bioenterics Corp.	2001	—

Also cleared against K002838: 2 other devices →

What descends from it? (1)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K173355	Gastric Sizing Balloon Catheter	Cook Incorporated	2017	0

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.
Of its descendants, K173355 (Cook Incorporated, 2017) has gone furthest, with 0 descendants of its own.
2 other devices also cite its predicate K002838.

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

2007high 16 (2014) · low 4 (2025)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · KNT

136in 2025

2007high 259 (2014) · low 99 (2016)2026

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

Recalls per year · KNT

13in 2025

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

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

Year	Decisions	Median 510(k) review, days	Recalls (Class I)	MAUDE reports
2007	10	118	1	300
2008	10	115	82	867
2009	11	102	9	818
2010	12	104	3	517
2011	7	211	2	531
2012	12	107	1	528
2013	7	128	0	747
2014	16	259	0	1,030
2015	10	140	1	1,048
2016	6	99	3	1,251
2017	9	247	4	1,672
2018	7	149	2	1,901
2019	10	126	2	1,838
2020	5	102	1	1,641
2021	6	121	2	1,655
2022	7	110	1 (1)	1,650
2023	5	162	2	1,863
2024	9	103	0	1,344
2025	4	136	13	1,451
2026	3	105	20	—

What is it indicated for?

The Cook Gastric Sizing Balloon Catheter is indicated for use in gastric and bariatric surgical procedures to size the gastric pouch and drain and remove gastric fluid.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K030841 · printed Nov 5, 2026

Cite this page

510(k) Report. “K030841: Cook Gastric Sizing Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K030841

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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