510(k) · Cleared
ClearedPulmoVia Working Channel
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Sanovas, Inc. · EOQ Bronchoscope (Flexible Or Rigid)
Cleared on Jun 11, 2015 as substantially equivalent to K131234 (Broncus Medical, Inc., 2013) and 1 other predicate after a 126-day review. Its family tree reaches back 3 generations to 1993. 1 of the 7 devices in its family, counting itself, has a Class I recall.
- Decided
- Jun 11, 2015
- Review
- 126 days
- Class
- Class II
- Product code
- EOQ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K931154 (1993). 6 ancestors in all, the oldest K923487 (1993). No later device cites it as a predicate yet. 1 of the 7 devices in this family, counting this one, has a Class I recall.
- Root · 3 generations backK931154 Evis 200 SystemOlympus Corp. · 1993
- 2 generations backK060243 Olympus Guide Sheath, Model XBO1-836-13Olympus Medical Systems Corporation · 2006 · Recalled (Class I)
- 1 generation backK131234 Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)Broncus Medical, Inc. · 2013
- This deviceK150280 PulmoVia Working ChannelSanovas, Inc. · 2015
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 |
|---|---|---|---|---|---|
| −3 | K931154 | Evis 200 System | Olympus Corp. | 1993 | — |
| −2 | K060243 | Olympus Guide Sheath, Model XBO1-836-13 | Olympus Medical Systems Corporation | 2006 | Class I |
| −1 | K131234 | Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon) | Broncus Medical, Inc. | 2013 | — |
| 0 (this device) | K150280 | PulmoVia Working Channel | Sanovas, Inc. | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
| 2002 | 1 | 0 |
| 2011 | 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 |
|---|---|---|---|
| * | K131234 | Lungpoint Tools (Lungpoint Sheath, Lungpoint Dilation Balloon)Summary page 4…tion: Class II Product Code: EOQ 3. PREDICATE DEVICES • LungPoint™ Tools (LungPoint Sheath and LungPoint Dilation Balloon), K131234 • KimVent BAL Cath Bronchial Aspirate Sampling Catheter, K112562 • Olympus Guide Sheath, K060243 4. DEVICE D… | 2013 |
| * | K112562 | Bal Cath Bronchial Aspirate Sampling CatheterSummary page 4…REDICATE DEVICES • LungPoint™ Tools (LungPoint Sheath and LungPoint Dilation Balloon), K131234 • KimVent BAL Cath Bronchial Aspirate Sampling Catheter, K112562 • Olympus Guide Sheath, K060243 4. DEVICE DESCRIPTION The PulmoVia Working Channel is a single-use disposable, t… | 2011 |
| † | K060243 | Olympus Guide Sheath, Model XBO1-836-13 | 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 · 2 generations back · ◆ on the line of descent in FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 4 companies; a new generation was cleared every 7.3 years on median.
- 1 of the 6 ancestors has a recall of any class; 1 has a Class I recall.
- 3 other devices also cite its predicate K131234.
How does its category compare?
All EOQ devicesEOQ Bronchoscope (Flexible Or Rigid): FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 PulmoVia Working Channel is intended to be used as an access channel through which a bronchoscope and other endoscopic tools may be introduced to treat targeted tissue of the airways. The PulmoVia Working Channel can also provide means for bronchoalveolar lavage. The PulmoVia Working Channel is indicated for adult patients.
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/K150280 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150280: PulmoVia Working Channel.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150280
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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