Cleared Traditional

K940306 - OCTOSTOP COMPENSATING FILTERS

K940306 is an FDA 510(k) clearance for OCTOSTOP COMPENSATING FILTERS, manufactured by Octostop, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 237-day FDA review.

K940306 · Octostop, Inc. · Radiology device
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Sep 1994
Decision
237d
Days
Class 2
Risk

K940306 is an FDA 510(k) clearance for the OCTOSTOP COMPENSATING FILTERS. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Octostop, Inc. (Montreal, Qc., CA). The FDA issued a Cleared decision on September 6, 1994 after a review of 237 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1680 - 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 Octostop, Inc. devices

FDA 510(k) Submission Details - K940306

510(k) Number K940306 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 12, 1994
Decision Date September 06, 1994
Days to Decision 237 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
130d slower than avg
Panel avg: 107d · This submission: 237d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPR Device Classification - Class 2, Special Controls

Product Code KPR System, X-ray, Stationary
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1680
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 - KPR System, X-ray, Stationary

All 215
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K940306.
VERTICAL INTEGRATED PERFECT VIEW (VIP) RADIOGRAPHIC SYSTEM
K952672 · Bennett X-Ray Corp. · Jul 1995
PHILIPS BUCKY DIAGNOST FAMILY
K945278 · Philips Medical Systems North America, Inc. · Dec 1994
PHILIPS THORAVISION
K931071 · Philips Medical Systems, Inc. · Sep 1994
BUCKY STAND BR-10M
K942792 · Shimadzu Corp. · Jul 1994
DIAGNOSTIC X-RAY PATIENT EXPOSURE INDICATOR
K941931 · Victoreen, Inc. · May 1994
WHIS-RAD TUBSTAND STRUCTURE/MOBILE PATIENT TROLLEY
K935649 · Bennett X-Ray Corp. · Feb 1994