510(k) · Cleared
ClearedVriicu System
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 Oct 15, 2008 as substantially equivalent to K061495 (Deep Breeze, Ltd., 2007) after a 300-day review. Its family tree reaches back 4 generations to 1977. 1 later device descends from it.
- Decided
- Oct 15, 2008
- Review
- 300 days
- Class
- Class II
- Product code
- OCR
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K771653 (1977). 7 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 4 generations backK771653 Electronic Stethoscope3M Company · 1977
- 3 generations backK961857 Labtron Electromax Electronic Stethoscope Model NO. 04-1060Graham-Field, Inc. · 1996
- 2 generations backK991367 Meditron Stethoscope SystemMeditron AS · 1999
- 1 generation backK061495 VR Lung ElectrosonographDeep Breeze, Ltd. · 2007
- This deviceK073582 Vriicu SystemDeep Breeze, Ltd. · 2008
- Descendant · cites it directly · 0 of its ownK091732 Vrlxp, Model XPDeep Breeze, Ltd. · 2010
Most influential descendants
Showing 1 of 1 · See all- K091732Vrlxp, Model XPDeep Breeze, Ltd. · 2010 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| −3 | K961857 | Labtron Electromax Electronic Stethoscope Model NO. 04-1060 | Graham-Field, Inc. | 1996 | — |
| −2 | K991367 | Meditron Stethoscope System | Meditron AS | 1999 | — |
| −1 | K061495 | VR Lung Electrosonograph | Deep Breeze, Ltd. | 2007 | — |
| 0 (this device) | 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 |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K061495 | VR Lung ElectrosonographSummary page 1…The VRIxv System is substantially equivalent to the previous version of the device, the VR Lung Electrosonograph (K061495). 000008 Device Description: T… | 2007 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K091732 | Vrlxp, Model XP | 2010 | 0 |
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 31 years and passes through 4 companies; a new generation was cleared every 8.0 years on median.
- None of the 7 ancestors has a recall.
- Of its descendants, K091732 (Deep Breeze, Ltd., 2010) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K061495.
How does its category compare?
All OCR devicesOCR Lung Sound Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 VRIxv is intended for use in monitoring and recording lung sounds.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073582 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073582: Vriicu System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073582
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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