510(k) · Cleared
ClearedVR Lung Electrosonograph
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Deep Breeze, Ltd. · OCR Lung Sound Monitor
Cleared on Jul 18, 2007 as substantially equivalent to K991367 (Meditron AS, 1999) after a 413-day review. Its family tree reaches back 3 generations to 1977. 2 later devices descend from it.
- Decided
- Jul 18, 2007
- Review
- 413 days
- Class
- Class II
- Product code
- OCR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K771653 (1977). 6 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK771653 Electronic Stethoscope3M Company · 1977
- 2 generations backK961857 Labtron Electromax Electronic Stethoscope Model NO. 04-1060Graham-Field, Inc. · 1996
- 1 generation backK991367 Meditron Stethoscope SystemMeditron AS · 1999
- This deviceK061495 VR Lung ElectrosonographDeep Breeze, Ltd. · 2007
- Descendant · cites it directly · 1 of its ownK073582 Vriicu SystemDeep Breeze, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK091732 Vrlxp, Model XPDeep Breeze, Ltd. · 2010
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| −2 | K961857 | Labtron Electromax Electronic Stethoscope Model NO. 04-1060 | Graham-Field, Inc. | 1996 | — |
| −1 | K991367 | Meditron Stethoscope System | Meditron AS | 1999 | — |
| 0 (this device) | K061495 | VR Lung Electrosonograph | Deep Breeze, Ltd. | 2007 | — |
| +1 | K073582 | Vriicu System | Deep Breeze, Ltd. | 2008 | — |
| +1 | K091732 | Vrlxp, Model XP | Deep Breeze, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 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 OCR? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin 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 |
|---|---|---|---|
| * | K991367 | Meditron Stethoscope SystemSummary page 2…erpretation calculator, 868.1900 Device Class: Class IL Predicate Device: Meditron Stethoscope System, Meditron AS (k991367) STG Monitor Multichannel Lung Sound Analysis System (k012387) Device D… | 1999 |
| † | K012387 | STG Multichannel Lung Sound Analysis System | 2002 |
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 30 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- None of the 6 ancestors has a recall.
- Of its descendants, K073582 (Deep Breeze, Ltd., 2008) has gone furthest, with 1 descendant of its own.
- 5 other devices also cite its predicate K991367.
How does its category compare?
All OCR devicesOCR Lung Sound Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2007, this device’s year, is highlighted.
FDA decisions per year · OCR
1in 2010
2026 to Oct 25, outlined.
Median 510(k) review, days · OCR
Too few OCR 510(k)s in any year since 2007 to give a median.
Recalls per year · OCR
No recall names OCR since 2007.
Adverse event reports per year · OCR
No MAUDE report names OCR since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 1 | — | 0 | 0 |
| 2008 | 1 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 1 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VR Lung Electrosonograph is intended for use in monitoring and recording lung sounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K061495 · printed Nov 6, 2026
Cite this page
510(k) Report. “K061495: VR Lung Electrosonograph.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K061495
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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