# K171188: Ossler Exam Scope

- Pathway: 510(k) (Traditional)
- Applicant: Lr Med, Inc.
- Decided: Jun 23, 2017 after 60 days
- Product code: DRG (Transmitters And Receivers, Physiological Signal, Radiofrequency)
- Device class: 2
- Regulation: 21 CFR 870.2910
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to K952882 (1996). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120704: 3M Littmann Telesteth Online Ausculation System, 3M Company (2012) Summary page 4.

## Cited in the summary but kept off the family tree
- K131243: Non-Contact Infrared Thermometer, Shenzhen Jumper Medical Equipment Co., Ltd. (2013). 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.

## Indications for use
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".

Source page: https://510kreport.com/device/K171188
Methodology: https://510kreport.com/methodology