510(k) · Cleared
ClearedLungFlow Airway Catheter
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Free Flow Medical, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Jul 10, 2026 as substantially equivalent to K060243 (Olympus Medical Systems Corporation, 2006) after a 206-day review. Its family tree reaches back 2 generations to 1993. 1 of the 3 devices in its family, counting itself, has a Class I recall.
- Decided
- Jul 10, 2026
- Review
- 206 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K931154 (1993). No later device cites it as a predicate yet. 1 of the 3 devices in this family, counting this one, has a Class I recall.
- Root · 2 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 1 generation backK060243 Olympus Guide Sheath, Model XBO1-836-13Olympus Medical Systems Corporation · 2006 · Recalled (Class I)
- This deviceK254037 LungFlow Airway CatheterFree Flow Medical, Inc. · 2026
Class I recalls in this family
- K060243 Olympus Guide Sheath, Model XBO1-836-13direct predicate · 2006
View FIG. 1 as a table
Line of descent and top descendants
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? (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 | Decided |
|---|---|---|---|
| * | K060243 | Olympus Guide Sheath, Model XBO1-836-13Summary page 5…subject of this submission, the LungFlow Airway Catheter, is substantially equivalent to the predicate, Olympus Guide Sheath, XBO1-836-13, cleared by FDA through 510(k) K060243. The subject device has the same intended use and similar indications for use, design, material, operational principles, and perf… | 2006 |
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 · Direct predicate · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 33 years and passes through 3 companies; a new generation was cleared every 20.0 years on median.
- 1 of the 2 ancestors has a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K060243.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 LungFlow Airway Catheter has been designed to be used with bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasonic probe to the targeted area within the respiratory organs.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K254037 · printed Nov 4, 2026
Cite this page
510(k) Report. “K254037: LungFlow Airway Catheter.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K254037
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026