510(k) Report

510(k) · Cleared

Cleared

ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40)

K242901510(k) TraditionalCleared Jan 10, 2025109-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

Tools For Surgery, LLC · KNT Tubes, Gastrointestinal (And Accessories)

Cleared on Jan 10, 2025 as substantially equivalent to K220218 (Tools For Surgery, LLC, 2022) after a 109-day review. Its family tree reaches back 4 generations to 2001.

Decided
Jan 10, 2025
Review
109 days
Class
Class II
Product code
KNT
Recalls
None
Predicates
1

Its longest line of descent runs back 4 generations to K002838 (2001). 5 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2007: 1 other ancestorReference device: K234145 · ViSiGi 3D Gastric Sizing Tube · Boehringer Laboratories · 2024Reference device: K130483 · Boehringer Gastric Sizing Tube · Boehringer Laboratories, LLC · 2013K002838 · Gastric Suction and Drainage Catheter · Bioenterics Corp. · 2001K110529 · Endoflip Gastric Tube · Crospon, Ltd. · 2011K130483 · Boehringer Gastric Sizing Tube · Boehringer Laboratories, LLC · 2013K220218 · Siren SGT · Tools For Surgery, LLC · 2022200020052010201520202025
Other ancestors, by generation 3 generations back: 1 other ancestor K220218 · Siren SGT · Tools For Surgery, LLC · 2022K130483 · Boehringer Gastric Sizing Tube · Boehringer Laboratories, LLC · 2013K110529 · Endoflip Gastric Tube · Crospon, Ltd. · 2011K002838 · Gastric Suction and Drainage Catheter · Bioenterics Corp. · 20010
  1. Root · 4 generations backK002838 Gastric Suction and Drainage CatheterBioenterics Corp. · 2001
  2. 3 generations backK110529 Endoflip Gastric TubeCrospon, Ltd. · 2011
  3. 2 generations backK130483 Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC · 2013
  4. 1 generation backK220218 Siren SGTTools For Surgery, LLC · 2022
  5. This deviceK242901 ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr…Tools For Surgery, LLC · 2025
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K002838Gastric Suction and Drainage CatheterBioenterics Corp.2001—
−3K110529Endoflip Gastric TubeCrospon, Ltd.2011—
−2K130483Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC2013—
−1K220218Siren SGTTools For Surgery, LLC2022—
0 (this device)K242901ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32)…Tools For Surgery, LLC2025—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
200710
FIG. 1 — Lineage of K242901, 2001–2025Source: 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
*K220218Siren SGT
Summary page 6
…and to test for leaks. The Inclusion of "to test for leaks" for ZZIREN™ Orogastric Tube differs from the indication stated for the primary predicate device in Submission K220218. "To test for leaks" is included in the indications for use of the secondary reference ViSiGi® 3D, which was cleared per Special…
Tools For Surgery, LLC2022—
†K234145ViSiGi 3D Gastric Sizing TubeBoehringer Laboratories2024—
†K130483Boehringer Gastric Sizing TubeBoehringer Laboratories, LLC2013—

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 24 years and passes through 4 companies; a new generation was cleared every 9.1 years on median.
  • None of the 5 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. 2025, this device’s year, is highlighted.

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 ZZIREN™ Orogastric Tube is indicated for use in gastric and bariatric surgical procedures for gastric aspiration and lavage, to serve as a size guide, and to test for leaks.

Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.

More from Tools For Surgery, LLC

4 FDA decisions under this applicant name. See the company

  • K220218Siren SGTTools For Surgery, LLC · 2022
  • K040109Hemorrhage Occluder PinTools For Surgery, LLC · 2004
  • K040110Easy Loop, Model Ezl-01Tools For Surgery, LLC · 2004

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/K242901 · printed Nov 5, 2026

Cite this page

510(k) Report. “K242901: ZZIREN™ Orogastric Tube; ZZIREN™ SGT Orogastric Tube - 32 Fr (ZZ-SGT-32); ZZIREN™ SGT Orogastric Tube - 36 Fr (ZZ-SGT-36); ZZIREN™ SGT Orogastric Tube - 40 Fr (ZZ-SGT-40); ZZIREN™ GBT Orogastric Tube - 32 Fr (ZZ-GBT-32); ZZIREN™ GBT Orogastric Tube - 36 Fr (ZZ-GBT-36); ZZIREN™ GBT Orogastric Tube - 40 Fr (ZZ-GBT-40).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K242901

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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