510(k) · Decided

Decided

Gastric Sizing Balloon Catheter

K173355510(k) SpecialDecided Nov 17, 201723-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 Incorporated · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Nov 17, 2017 as substantially equivalent to K030841 (Cook, Inc., 2003) after a 23-day review. Its family tree reaches back 2 generations to 2001.

Decided: Nov 17, 2017
Review: 23 days
Class: Class II
Product code: KNT
Recalls: None
Predicates: 1

Its longest line of descent runs back 2 generations to K002838 (2001). No later device cites it as a predicate yet.

By dateBy generation

Root · 2 generations backK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
1 generation backK030841 Cook Gastric Sizing Balloon CatheterCook, Inc. · 2003
This deviceK173355 Gastric Sizing Balloon CatheterCook Incorporated · 2017

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−2	K002838	Gastric Suction and Drainage Catheter	Bioenterics Corp.	2001	—
−1	K030841	Cook Gastric Sizing Balloon Catheter	Cook, Inc.	2003	—
0 (this device)	K173355	Gastric Sizing Balloon Catheter	Cook Incorporated	2017	—

FIG. 1 — Lineage of K173355, 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
*	K030841	Cook Gastric Sizing Balloon Catheter Summary page 4 …Gastroenterology/Urology Regulation: 21 CFR § 876.5980 Product Code: KNT Predicate Devices:  Cook Gastric Sizing Balloon Catheter (K030841) Device Description: The Gastric Sizing Balloon Catheter is an invasive device that consists of a 55 cm flexible gastric tube de…	Cook, Inc.	2003	—

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?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 14.4 years on median.
None of the 2 ancestors has a recall.

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. 2017, this device’s year, is highlighted.

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 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/K173355 · printed Nov 6, 2026

Cite this page

510(k) Report. “K173355: Gastric Sizing Balloon Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K173355

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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