Cleared Traditional

K811211 - YOSHIDA AP 100

K811211 is an FDA 510(k) clearance for YOSHIDA AP 100, manufactured by Kaycor Intl., Ltd.. The device is a Class 2 Radiology device with product code EGY cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K811211 · Kaycor Intl., Ltd. · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 1981
Decision
43d
Days
Class 2
Risk

K811211 is an FDA 510(k) clearance for the YOSHIDA AP 100. Classified as Processor, Radiographic-film, Automatic, Dental (product code EGY), Class II - Special Controls.

Submitted by Kaycor Intl., Ltd. (Mchenry, US). The FDA issued a Cleared decision on June 16, 1981 after a review of 43 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1900 - 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 Kaycor Intl., Ltd. devices

FDA 510(k) Submission Details - K811211

510(k) Number K811211 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1981
Decision Date June 16, 1981
Days to Decision 43 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
64d faster than avg
Panel avg: 107d · This submission: 43d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

EGY Device Classification - Class 2, Special Controls

Product Code EGY Processor, Radiographic-film, Automatic, Dental
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1900
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 - EGY Processor, Radiographic-film, Automatic, Dental

Devices cleared under the same product code (EGY) and FDA review panel - the closest regulatory comparables to K811211.
DXSS AUTOMATIC X-RAY FILM PROCESSOR, (MODELS #S: 512, 1530, 812, 830)
K992896 · Dental X-Ray Support Systems, Inc. · Sep 1999
SMITH S-100 TIME & TEMPERATURE CONTROL
K955825 · Smith Companies Dental Products · Apr 1996
ALARA IMAGING SYSTEM
K955643 · Denoptix, Inc. · Mar 1996
FILM PROCESSOR, AUTOMATIC
K770783 · General Electric Co. · May 1977