Cleared Traditional

K211350 - Bindex BI-2 (FDA 510(k) Clearance)

Class II Radiology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K211350 · Bone Index Finland , Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2022
Decision
361d
Days
Class 2
Risk

K211350 is an FDA 510(k) clearance for the Bindex BI-2. Classified as Bone Sonometer (product code MUA), Class II - Special Controls.

Submitted by Bone Index Finland , Ltd. (Kuopio, FI). The FDA issued a Cleared decision on April 29, 2022 after a review of 361 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1180 - the FDA radiology and imaging software 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Radiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Bone Index Finland , Ltd. devices

Submission Details

510(k) Number K211350 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 03, 2021
Decision Date April 29, 2022
Days to Decision 361 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
254d slower than avg
Panel avg: 107d · This submission: 361d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MUA Bone Sonometer
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1180
Definition A Bone Sonometer Is A Device That Transmits Ultrasound Energy Into The Human Body To Measure Acoustic Properties Of Bone That Indicate Overall Bone Health And Fracture Risk. The Primary Components Of The Device Are A Voltage Generator, A Transmitting Transducer, A Receiving Transducer, And Hardware And Software For Reception And Processing Of The Received Ultrasonic Signal. Reclassified From Class 3 Pma To Class 2 510(k) 892.1180 [docket No. Fda-2005-n-0346] Reclassification Of Bone Sonometers
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 Radiology devices follow this clearance model.