Cleared Traditional

K842687 - BIOMEDICS BLADDER SCANNER

K842687 is an FDA 510(k) clearance for BIOMEDICS BLADDER SCANNER, manufactured by Biomedics. The device is a Class 2 Radiology device with product code ITX cleared through the Traditional 510(k) pathway after a 272-day FDA review.

K842687 · Biomedics · Radiology device
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Apr 1985
Decision
272d
Days
Class 2
Risk

K842687 is an FDA 510(k) clearance for the BIOMEDICS BLADDER SCANNER. Classified as Transducer, Ultrasonic, Diagnostic (product code ITX), Class II - Special Controls.

Submitted by Biomedics (Mercer Island, US). The FDA issued a Cleared decision on April 8, 1985 after a review of 272 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1570 - 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. Standard predicate reliance. 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 Biomedics devices

FDA 510(k) Submission Details - K842687

510(k) Number K842687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 10, 1984
Decision Date April 08, 1985
Days to Decision 272 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
165d slower than avg
Panel avg: 107d · This submission: 272d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

ITX Device Classification - Class 2, Special Controls

Product Code ITX Transducer, Ultrasonic, Diagnostic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1570
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.

Regulatory Peers - ITX Transducer, Ultrasonic, Diagnostic

All 299
Devices cleared under the same product code (ITX) and FDA review panel - the closest regulatory comparables to K842687.
CONVEX PROBE, PVE-393M
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K852132 · Hewlett-Packard Co. · Aug 1985
CIVCO-SUPER SCAN/BIOPSY GUIDE
K843573 · CIVCO Medical Instruments Co., Inc. · Dec 1984
3.5 MHZ BIOPSY TRANSDUCER
K812929 · General Electric Co. · Nov 1981
BIOPSY TRANSDUCER
K811843 · Siemens Gammasonics, Inc. · Aug 1981