510(k) · Cleared
ClearedOssler Exam Scope
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Lr Med, Inc. · DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Cleared on Jun 23, 2017 as substantially equivalent to K120704 (3M Company, 2012) after a 60-day review. Its family tree reaches back 5 generations to 1996.
- Decided
- Jun 23, 2017
- Review
- 60 days
- Class
- Class II
- Product code
- DRG
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to K952882 (1996). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK952882 Personal Telemedicine SystemAmerican Telecare, Inc. · 1996
- 4 generations backK964554 Personal Telemedicine ModuleAmerican Telecare, Inc. · 1996
- 3 generations backK973873 Digital Personal Telemedicine Module, Digital PTM 1American Telecare, Inc. · 1997
- 2 generations backK101834 3M Littmann Scope-to Scope Software System3M Company · 2010
- 1 generation backK120704 3M Littmann Telesteth Online Ausculation System3M Company · 2012
- This deviceK171188 Ossler Exam ScopeLr Med, Inc. · 2017
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K952882 | Personal Telemedicine System | American Telecare, Inc. | 1996 | — |
| −4 | K964554 | Personal Telemedicine Module | American Telecare, Inc. | 1996 | — |
| −3 | K973873 | Digital Personal Telemedicine Module, Digital PTM 1 | American Telecare, Inc. | 1997 | — |
| −2 | K101834 | 3M Littmann Scope-to Scope Software System | 3M Company | 2010 | — |
| −1 | K120704 | 3M Littmann Telesteth Online Ausculation System | 3M Company | 2012 | — |
| 0 (this device) | K171188 | Ossler Exam Scope | Lr Med, Inc. | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 DRG? 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 DRG device
- #1 K223711 ANNE Onescore 20.8 · 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K120704 | 3M Littmann Telesteth Online Ausculation SystemSummary page 4…iagnostics Devices Device Classification Class II Establishment registration No. N/A Predicate Device K120704 3M Littman® TeleSteth Online Auscultation System K131243 Model JPD-FR100 Trademark… | 2012 |
| Kept off the family tree | K131243 | FDA’s K131243 is Non-Contact Infrared Thermometer Our reading of the summary gave K131243, FDA’s number for Non-Contact Infrared Thermometer (Shenzhen Jumper Medical Equipment Co., Ltd.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Model JPD-FR100”. Kept off the family tree. Summary page 4…o. N/A Predicate Device K120704 3M Littman® TeleSteth Online Auscultation System K131243 Model JPD-FR100 Trademark Notice: All Trademarks used other than those of LR Med Inc, a/k/a Galenus Scientific are registered to… | 2013 |
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 21 years and passes through 3 companies; a new generation was cleared every 1.7 years on median.
- None of the 6 ancestors has a recall.
How does its category compare?
All DRG devicesDRG Transmitters And Receivers, Physiological Signal, Radiofrequency: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · DRG
3in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DRG
127in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DRG
3in 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DRG
52in 2025
MAUDE reports naming product code DRG, 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 | 6 | 63 | 3 | 14 |
| 2008 | 5 | 74 | 0 | 9 |
| 2009 | 13 | 94 | 0 | 5 |
| 2010 | 10 | 68 | 0 | 13 |
| 2011 | 9 | 104 | 0 | 12 |
| 2012 | 12 | 103 | 0 | 9 |
| 2013 | 13 | 146 | 0 | 13 |
| 2014 | 10 | 177 | 0 | 97 |
| 2015 | 2 | — | 0 | 131 |
| 2016 | 2 | — | 0 | 182 |
| 2017 | 7 | 98 | 0 | 484 |
| 2018 | 6 | 220 | 0 | 166 |
| 2019 | 5 | 122 | 0 | 70 |
| 2020 | 6 | 159 | 0 | 82 |
| 2021 | 2 | — | 0 | 107 |
| 2022 | 6 | 287 | 0 | 43 |
| 2023 | 4 | 212 | 0 | 19 |
| 2024 | 3 | 125 | 0 | 26 |
| 2025 | 3 | 127 | 0 | 52 |
| 2026 | 2 | — | 1 | — |
What is it indicated for?
Ossler Exam Scope, Model OS 100 is indicated to detect and amplify heart, lung, and other body sounds as well as to measure body temperature for infants and adults for diagnostic or monitoring purposes on a patient where by the patient will benefit by uploading these data for diagnostic consultation. This does shall not be prescribed for "active patient monitoring".
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171188 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171188: Ossler Exam Scope.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171188
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