510(k) · Cleared
ClearedYield Mini Doppler System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Broncus Technologies, Inc. · IYN System, Imaging, Pulsed Doppler, Ultrasonic
Cleared on Apr 3, 2009 as substantially equivalent to K010649 (Broncus Technologies, Inc., 2001) and 1 other predicate after a 14-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Apr 3, 2009
- Review
- 14 days
- Class
- Class II
- Product code
- IYN
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K851141 (1985). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK851141 Teleflex Medical Introducer CatheterTeleflexmedical, Inc. · 1985
- 2 generations backK963989 P.D. Access (Percutaneous Doppler) Vascular Access DeviceCardiovascular Dynamics, Inc. · 1997
- 1 generation backK973713 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle…Cardiovascular Dynamics, Inc. · 1998
- This deviceK090743 Yield Mini Doppler SystemBroncus Technologies, Inc. · 2009
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K851141 | Teleflex Medical Introducer Catheter | Teleflexmedical, Inc. | 1985 | — |
| −2 | K963989 | P.D. Access (Percutaneous Doppler) Vascular Access Device | Cardiovascular Dynamics, Inc. | 1997 | — |
| −1 | K973713 | 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24… | Cardiovascular Dynamics, Inc. | 1998 | — |
| 0 (this device) | K090743 | Yield Mini Doppler System | Broncus Technologies, Inc. | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1991 | 1 | 0 |
| 1992 | 1 | 0 |
| 1994 | 1 | 0 |
| 2001 | 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.
Planning a device in IYN? 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 IYN device
- #1 K240850 EPIQ Series Diagnostic Ultrasound Systems…score 32.1 · 24 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 |
|---|---|---|---|
| * | K010649 | Exhale Doppler SystemSummary page 1…ode IYN 4. Predicate Device The predicate devices identified for the Yield Mini Doppler Probe are as follows: Exhale Doppler System Broncus K010649, cleared to market Technologies, Inc on March 20, 2001 P.D. Access Percutaneous Card… | 2001 |
| * | K973713 | 22 Gauge P.D. Access Vascular Access Device (Catheter/Needle Assembly), 24 Gauge P.D.…Summary page 1…K010649, cleared to market Technologies, Inc on March 20, 2001 P.D. Access Percutaneous Cardiovascular K973713, cleared to market Doppler Vascular Device Dynamics, Inc on January 23, 1998 and P.D. Access Dual Frequency… | 1998 |
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 3 companies; a new generation was cleared every 11.2 years on median.
- 1 of the 8 ancestors has a recall of any class.
- 1 other device also cites its predicate K010649.
How does its category compare?
All IYN devicesIYN System, Imaging, Pulsed Doppler, Ultrasonic: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · IYN
57in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · IYN
124in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · IYN
10in 2025
Class I (1 since 2007) Class II/III not classified
Adverse event reports per year · IYN
610in 2025
MAUDE reports naming product code IYN, 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 | 13 | 26 | 16 | 3 |
| 2008 | 25 | 18 | 12 | 2 |
| 2009 | 18 | 29 | 8 | 9 |
| 2010 | 29 | 67 | 10 | 17 |
| 2011 | 39 | 46 | 8 | 18 |
| 2012 | 43 | 37 | 3 | 20 |
| 2013 | 51 | 60 | 8 | 18 |
| 2014 | 56 | 39 | 2 | 48 |
| 2015 | 54 | 55 | 3 | 116 |
| 2016 | 60 | 56 | 2 | 145 |
| 2017 | 64 | 83 | 0 | 146 |
| 2018 | 59 | 85 | 7 | 85 |
| 2019 | 47 | 79 | 0 | 59 |
| 2020 | 57 | 72 | 4 | 67 |
| 2021 | 46 | 105 | 8 | 213 |
| 2022 | 53 | 105 | 10 | 186 |
| 2023 | 44 | 115 | 4 | 229 |
| 2024 | 50 | 119 | 1 | 266 |
| 2025 | 57 | 124 | 10 | 610 |
| 2026 | 44 | 107 | 2 (1) | — |
What is it indicated for?
The Yield Mini Doppler Probe with Broncus® Monitor is intended for use through a bronchoscope to detect blood flow behind airway walls in the tracheobronchial tree.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090743 · printed Nov 6, 2026
Cite this page
510(k) Report. “K090743: Yield Mini Doppler System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K090743
Report an extraction error
Are you the manufacturer?
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