510(k) Report

510(k) · Cleared

Cleared

Bronchial Catheter System

K980046510(k) TraditionalCleared May 1, 1998115-day reviewClass II21 CFR 874.4680

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

Broncus Technologies, Inc. · EOQ Bronchoscope (Flexible Or Rigid)

Cleared on May 1, 1998 after a 115-day review. The FDA summary names its predicate without a number. 44 later devices descend from it.

Decided
May 1, 1998
Review
115 days
Class
Class II
Product code
EOQ
Recalls
None
Predicates
0

44 later devices descend from it, 2 citing it directly.

Descendants, by year cleared 2002: 1 descendant cleared2001: 1 descendant cleared2003: 3 descendants cleared2004: 3 descendants cleared2005: 1 descendant cleared2010: 3 descendants cleared2006: 5 descendants cleared2008: 2 descendants cleared2012: 2 descendants cleared2014: 2 descendants cleared2019: 2 descendants cleared2013: 1 descendant cleared2009: 3 descendants cleared2007: 1 descendant cleared2015: 1 descendant cleared2017: 2 descendants cleared2018: 2 descendants cleared2016: 2 descendants cleared2024: 2 descendants cleared2021: 3 descendants cleared2025: 1 descendant cleared2020: 1 descendant cleared1995200020052010201520202025
  1. This deviceK980046 Bronchial Catheter SystemBroncus Technologies, Inc. · 1998
  2. Descendant · cites it directly · 42 of its ownK023765 Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002
  3. Descendant · cites it directly · 42 of its ownK013139 Stellartech Coagulation SystemStellartech Research Corp. · 2001
  4. Descendant · 2 generations on · 41 of its ownK032062 Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003
  5. Descendant · 2 generations on · 39 of its ownK032452 Modification to: Stellartech Coagulation System, Models 1100C-115 &…Stellartech Research Corp. · 2003
  6. Descendant · 2 generations on · 38 of its ownK032721 Modification to: Stellartech Coagulation System (Models 1100C-115 &…Stellartech Research Corp. · 2003

Showing 5 of 44 descendants. See all descendants

Descendants cleared per year

2001: 12002: 12003: 32004: 32005: 12006: 52007: 12008: 22009: 32010: 32012: 22013: 12014: 22015: 12016: 22017: 22018: 22019: 22020: 12021: 32024: 22025: 1
2001high 5 (2006) · low 0 (2011)2026

Most influential descendants

Showing 5 of 44 · See all
  • K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2002 · cites it directly42descendants
  • K013139Stellartech Coagulation SystemStellartech Research Corp. · 2001 · cites it directly42descendants
  • K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp. · 2003 · 2 generations on41descendants
  • K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp. · 2003 · 2 generations on39descendants
  • K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp. · 2003 · 2 generations on38descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
0 (this device)K980046Bronchial Catheter SystemBroncus Technologies, Inc.1998—
+1K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.2002—
+1K013139Stellartech Coagulation SystemStellartech Research Corp.2001—
+2K032062Stellartech Coagulation System, Models (1100C-115 & 1100C-230)Stellartech Research Corp.2003—
+2K032452Modification to: Stellartech Coagulation System, Models 1100C-115 & 100C-230Stellartech Research Corp.2003—
+2K032721Modification to: Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.2003—

Descendants by year cleared

Year clearedDevicesWith a Class I recall
200110
200210
200330
200430
200510
200650
200710
200820
200930
201030
201220
201310
201420
201510
201620
201720
201820
201920
202010
202130
202420
202510
FIG. 1 — Lineage of K980046, 1998–2025Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

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 EOQ? 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 EOQ device

  1. #1 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (3)

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
*—Olympus Disposable Balloon Catheters
Named without a submission number
—
*—Boston Scientific Microvasive Gold Probe Direct
Named without a submission number
—
*—Valleylab, Inc. Force 2 Electrosurgical Generator
Named without a submission number
—

What descends from it? (44)

See all 44

2 later devices cite it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K023765Stellartech Coagulation System (Models 1100C-115 & 1100C-230)Stellartech Research Corp.200242
K013139Stellartech Coagulation SystemStellartech Research Corp.200142

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, K023765 (Stellartech Research Corp., 2002) has gone furthest, with 42 descendants of its own.

How does its category compare?

All EOQ devices

EOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years.

FDA decisions per year · EOQ

20in 2025

2007: 22008: 22009: 32012: 22013: 42014: 32015: 62016: 32017: 42018: 72019: 112020: 102021: 152022: 112023: 122024: 132025: 202026 (partial year): 9
2007high 20 (2025) · low 0 (2010)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · EOQ

147in 2025

2009: 24 days median2013: 178 days median2014: 302 days median2015: 206 days median2016: 262 days median2017: 136 days median2018: 212 days median2019: 147 days median2020: 103 days median2021: 169 days median2022: 134 days median2023: 160 days median2024: 130 days median2025: 147 days median2026 (partial year): 206 days median
2007high 302 (2014) · low 24 (2009)2026

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

Recalls per year · EOQ

25in 2025

2011: 12012: 42016: 12019: 12020: 12021: 92022: 52023: 18, 4 Class I2024: 42025: 25, 24 Class I
2007high 25 (2025) · low 0 (2007)2026

Class I (28 since 2007) Class II/III not classified

Adverse event reports per year · EOQ

6,546in 2025

2007: 392008: 872009: 1142010: 1002011: 962012: 932013: 932014: 982015: 1322016: 2972017: 3372018: 2792019: 6542020: 5152021: 1,3582022: 2,5412023: 5,0642024: 6,0512025: 6,546
2007high 6,546 (2025) · low 39 (2007)2025

MAUDE reports naming product code EOQ, 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
20072—039
20082—087
20093240114
20100—0100
20110—196
20122—493
20134178093
20143302098
201562060132
201632621297
201741360337
201872120279
2019111471654
2020101031515
20211516991,358
20221113452,541
20231216018 (4)5,064
20241313046,051
20252014725 (24)6,546
202692060—

What is it indicated for?

The Bronchial Catheter System is intended for foreign body removal and bronchial hemostasis.

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

More from Broncus Technologies, Inc.

11 FDA decisions under this applicant name. See the company

  • K112051Lungpoint Planning and Virtual Bronchoscopic Navigation (VBN) SoftwareBroncus Technologies, Inc. · 2011
  • K093423Lungpoint Procedure PlanningBroncus Technologies, Inc. · 2009
  • K091160Lungpoint Virtual Bronchoscopic Navigation VBN SystemBroncus Technologies, Inc. · 2009
  • K090853Yield Tissue SamplerBroncus Technologies, Inc. · 2009
  • K090743Yield Mini Doppler SystemBroncus Technologies, Inc. · 2009

Recent decisions in EOQ

The EOQ category page

  • K261637Single-use Flexible BronchoscopeHunan Vathin Medical Instrument Co., Ltd. · 2026
  • K260309Ambu® aScope™ 5 Broncho 2.7/1.2; Ambu® aScope™ 5 Broncho 4.2/2.2; Ambu® aScope™ 5 Broncho 4.2/2.2 Sampler SetAmbu A/S · 2026
  • K2540263.8mm Slim ProVu Video Bronchoscope (090-02-0038U); 5.0mm Regular ProVu Video Bronchoscope (090-02-0050U)…Flexicare Medical Limited. · 2026
  • K260382MONARCH™ Platform (MON-000008)Auris Health, Inc. · 2026
  • K254037LungFlow Airway CatheterFree Flow Medical, Inc. · 2026

https://510kreport.com/device/K980046 · printed Nov 6, 2026

Cite this page

510(k) Report. “K980046: Bronchial Catheter System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K980046

Report an extraction error

Tell us what is wrong; we check it against the FDA summary.

Are you the manufacturer?

Send a correction or an update to this page, for example a newer model or a public statement about a recall.

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