Cleared Traditional

K810914 - 5CM SMALL PARTS SCANNER

K810914 is the FDA 510(k) clearance for 5CM SMALL PARTS SCANNER by Smithkline Diagnostics, Inc.. It is a Class 2 Radiology device (product code IYO) cleared through the Traditional 510(k) pathway after a 32-day FDA review.

K810914 · Smithkline Diagnostics, Inc. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1981
Decision
32d
Days
Class 2
Risk

K810914 is an FDA 510(k) clearance for the 5CM SMALL PARTS SCANNER. Classified as System, Imaging, Pulsed Echo, Ultrasonic (product code IYO), Class II - Special Controls.

Submitted by Smithkline Diagnostics, Inc. (Walker, US). The FDA issued a Cleared decision on May 8, 1981 after a review of 32 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1560 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Smithkline Diagnostics, Inc. devices

Submission Details

510(k) Number K810914 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1981
Decision Date May 08, 1981
Days to Decision 32 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d faster than avg
Panel avg: 107d · This submission: 32d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYO System, Imaging, Pulsed Echo, Ultrasonic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1560
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 - IYO System, Imaging, Pulsed Echo, Ultrasonic

All 387
Devices cleared under the same product code (IYO) and FDA review panel - the closest regulatory comparables to K810914.
ARTICULATED ARM B-SCANNER
K811426 · General Electric Co. · Aug 1981
ATL'S MARK 100/300 ULTRASOUND SYSTEMS
K811572 · Advanced Technology Laboratories, Inc. · Aug 1981
MS-50 ULTRASONIC IMAGER
K811252 · Kontron Instruments, Inc. · Aug 1981
OPHTHALMO ECHOGRAPH MODEL ZD255G
K802635 · Jedmed Instrument Co. · Apr 1981
MARK 500 SYSTEM
K810073 · Advanced Technology Laboratories, Inc. · Mar 1981
VARIAN V3500 PHASED ARRAY ULTRASONOGRAPH
K802434 · Varian Assoc., Inc. · Feb 1981