Cleared Traditional

K171188 - Ossler Exam Scope

K171188 is an FDA 510(k) clearance for Ossler Exam Scope, manufactured by Lr Med, Inc.. The device is a Class 2 Cardiovascular device with product code DRG cleared through the Traditional 510(k) pathway after a 60-day FDA review.

K171188 · Lr Med, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2017
Decision
60d
Days
Class 2
Risk

K171188 is an FDA 510(k) clearance for the Ossler Exam Scope. Classified as Transmitters And Receivers, Physiological Signal, Radiofrequency (product code DRG), Class II - Special Controls.

Submitted by Lr Med, Inc. (Burr Ridge, US). The FDA issued a Cleared decision on June 23, 2017 after a review of 60 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2910 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K171188

510(k) Number K171188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 24, 2017
Decision Date June 23, 2017
Days to Decision 60 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
65d faster than avg
Panel avg: 125d · This submission: 60d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DRG Device Classification - Class 2, Special Controls

Product Code DRG Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2910
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Consultant

Compliance Consultants
Richard Keen

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DRG Transmitters And Receivers, Physiological Signal, Radiofrequency

All 185
Devices cleared under the same product code (DRG) and FDA review panel - the closest regulatory comparables to K171188.
VitalPatch® VitalConnect Platform
K163453 · Vitalconnect, Inc. · Nov 2017
Optum TeleHealth Application
K171406 · United Health Group, Inc. · Aug 2017
eCareCoordinator
K171029 · Visicu, Inc. · Jul 2017
VitalWatch Software User Interface
K170973 · Vitalconnect, Inc. · Jun 2017
FFR Link, FFR Signal Processing Module
K170204 · Boston Scientific Corporation · Mar 2017
TelePatch Cardiac Monitor
K161916 · Medicomp, Inc. · Dec 2016
K171188 · Ossler Exam Scope
Download PDF FDA Summary Lr Med, Inc.