510(k) · Cleared
ClearedEasyPath RF Introducer Sheath
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Broncus Medical, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Jan 14, 2021 as substantially equivalent to K183240 (Broncus Medical, Inc., 2019) and 1 other predicate after a 302-day review. Its family tree reaches back 4 generations to 1996. 1 of the 9 devices in its family, counting itself, has a Class I recall.
- Decided
- Jan 14, 2021
- Review
- 302 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 4 generations to K955247 (1996). 8 ancestors in all, the oldest K931154 (1993). No later device cites it as a predicate yet. 1 of the 9 devices in this family, counting this one, has a Class I recall.
- Root · 4 generations backK955247 Olympus KD Series SphincterotomeOlympus America, Inc. · 1996
- 3 generations backK971328 Olympus CD-6C-1 Coagulation ElectrodeOlympus America, Inc. · 1997
- 2 generations backK120909 EC 2.7 Endoscopic CutterMedtronic Advanced Energy, LLC · 2012
- 1 generation backK183240 Empower RF CatheterBroncus Medical, Inc. · 2019
- This deviceK200702 EasyPath RF Introducer SheathBroncus Medical, Inc. · 2021
Class I recalls in this family
- K060243 Olympus Guide Sheath, Model XBO1-836-132 generations back · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K955247 | Olympus KD Series Sphincterotome | Olympus America, Inc. | 1996 | — |
| −3 | K971328 | Olympus CD-6C-1 Coagulation Electrode | Olympus America, Inc. | 1997 | — |
| −2 | K120909 | EC 2.7 Endoscopic Cutter | Medtronic Advanced Energy, LLC | 2012 | — |
| −1 | K183240 | Empower RF Catheter | Broncus Medical, Inc. | 2019 | — |
| 0 (this device) | K200702 | EasyPath RF Introducer Sheath | Broncus Medical, Inc. | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2002 | 1 | 0 |
| 2006 | 1 | 1 |
| 2013 | 1 | 0 |
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.
1 device in this family has a Class I recall. 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 K223299 Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu®…score 18.4 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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 | Decided |
|---|---|---|---|
| * | K183240 | Empower RF CatheterSummary page 4…rmation: Primary Predicate Device Manufacturer 510(k)# Clearance Date Empower RF Catheter Broncus Medical, Inc. K183240 February 22, 2019 Secondary Predicate Manufacturer 510(k)# C… | 2019 |
| * | K131234 | Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)Summary page 4…510(k)# Clearance Date Device Archimedes Sheath (current commercial name) [Cleared as LungPoint Broncus Medical, Inc. K131234 October 15, 2013 Tools: LungPoint Sheath and LungPoint Dilation Balloon] V. DEVICE DESCRIPTION… | 2013 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K060243Olympus Guide Sheath, Model XBO1-836-13Olympus Medical Systems Corporation · 2006 · 2 generations back · ◆ in the 2006 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 25 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 8 ancestors has a recall of any class; 1 has a Class I recall.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, this device’s year, is highlighted.
FDA decisions per year · EOQ
20in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · EOQ
147in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · EOQ
25in 2025
Class I (28 since 2007) Class II/III not classified
Adverse event reports per year · EOQ
6,546in 2025
MAUDE reports naming product code EOQ, 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 | 2 | — | 0 | 39 |
| 2008 | 2 | — | 0 | 87 |
| 2009 | 3 | 24 | 0 | 114 |
| 2010 | 0 | — | 0 | 100 |
| 2011 | 0 | — | 1 | 96 |
| 2012 | 2 | — | 4 | 93 |
| 2013 | 4 | 178 | 0 | 93 |
| 2014 | 3 | 302 | 0 | 98 |
| 2015 | 6 | 206 | 0 | 132 |
| 2016 | 3 | 262 | 1 | 297 |
| 2017 | 4 | 136 | 0 | 337 |
| 2018 | 7 | 212 | 0 | 279 |
| 2019 | 11 | 147 | 1 | 654 |
| 2020 | 10 | 103 | 1 | 515 |
| 2021 | 15 | 169 | 9 | 1,358 |
| 2022 | 11 | 134 | 5 | 2,541 |
| 2023 | 12 | 160 | 18 (4) | 5,064 |
| 2024 | 13 | 130 | 4 | 6,051 |
| 2025 | 20 | 147 | 25 (24) | 6,546 |
| 2026 | 9 | 206 | 0 | — |
What is it indicated for?
The EasyPath RF Introducer Sheath is a single-use device intended to be used with flexible bronchoscopes as a working channel through which endoscopic tools may be introduced to target tissue. It is indicated for electrosurgical procedures involving cutting and coagulation of soft tissue in the upper airways and tracheobronchial tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K200702 · printed Nov 6, 2026
Cite this page
510(k) Report. “K200702: EasyPath RF Introducer Sheath.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K200702
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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