510(k) · Cleared
ClearedVrlxp, Model XP
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 Mar 4, 2010 as substantially equivalent to K073582 (Deep Breeze, Ltd., 2008) and 2 other predicates after a 266-day review. Its family tree reaches back 5 generations to 1977.
- Decided
- Mar 4, 2010
- Review
- 266 days
- Class
- Class II
- Product code
- OCR
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 5 generations to K771653 (1977). 8 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK771653 Electronic Stethoscope3M Company · 1977
- 4 generations backK961857 Labtron Electromax Electronic Stethoscope Model NO. 04-1060Graham-Field, Inc. · 1996
- 3 generations backK991367 Meditron Stethoscope SystemMeditron AS · 1999
- 2 generations backK061495 VR Lung ElectrosonographDeep Breeze, Ltd. · 2007
- 1 generation backK073582 Vriicu SystemDeep Breeze, Ltd. · 2008
- This deviceK091732 Vrlxp, Model XPDeep Breeze, Ltd. · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K771653 | Electronic Stethoscope | 3M Company | 1977 | — |
| −4 | K961857 | Labtron Electromax Electronic Stethoscope Model NO. 04-1060 | Graham-Field, Inc. | 1996 | — |
| −3 | K991367 | Meditron Stethoscope System | Meditron AS | 1999 | — |
| −2 | K061495 | VR Lung Electrosonograph | Deep Breeze, Ltd. | 2007 | — |
| −1 | K073582 | Vriicu System | Deep Breeze, Ltd. | 2008 | — |
| 0 (this device) | K091732 | Vrlxp, Model XP | Deep Breeze, Ltd. | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1996 | 3 | 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? (3)
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 |
|---|---|---|---|
| * | K073582 | Vriicu SystemSummary page 1…cation Name: Electronic Stethoscope Device Class: Class 11, 21 CFR 870.1875(b) Product Code OCR Predicate Devices: VRlxv (K073 582) Deep Breeze, Ltd. Class 1I VR Lung Electrosonograph… | 2008 |
| * | K061495 | VR Lung ElectrosonographSummary page 1…redicate Devices: VRlxv (K073 582) Deep Breeze, Ltd. Class 1I VR Lung Electrosonograph (K06 1495) Deep Breeze, Ltd. Class LI… | 2007 |
| * | K991367 | Meditron Stethoscope SystemSummary page 2…000060 Meditron Stethoscope System (K99 1367) Meditron AS Class II STG Monitor Mult… | 1999 |
| † | K012387 | STG Multichannel Lung Sound Analysis System | 2002 |
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 33 years and passes through 4 companies; a new generation was cleared every 3.0 years on median.
- None of the 8 ancestors has a recall.
How does its category compare?
All OCR devicesOCR Lung Sound Monitor: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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 VR1xp is intended for monitoring and recording lung sounds and automatic detection of crackles and wheezes. When interpreted by physicians with general medical training and experience, the VRlxp aids in diagnosis and patient management. The VRlxp is intended to be used in healthcare facilities on adults, adolescents, and/or children over the height of 2 feet 9 inches.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K091732 · printed Nov 4, 2026
Cite this page
510(k) Report. “K091732: Vrlxp, Model XP.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K091732
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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