Cleared Traditional

K902378 - CARDIOTHORACIC RULER

K902378 is an FDA 510(k) clearance for CARDIOTHORACIC RULER, manufactured by Devcom, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K902378 · Devcom, Inc. · Radiology device
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Jun 1990
Decision
16d
Days
Class 2
Risk

K902378 is an FDA 510(k) clearance for the CARDIOTHORACIC RULER. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Devcom, Inc. (Paoli, US). The FDA issued a Cleared decision on June 14, 1990 after a review of 16 days - a notably fast clearance 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: 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 Devcom, Inc. devices

FDA 510(k) Submission Details - K902378

510(k) Number K902378 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 29, 1990
Decision Date June 14, 1990
Days to Decision 16 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 107d · This submission: 16d
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 284
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K902378.
NEURO VISION RADIOGRAPHIC X-RAY SYSTEM
K904146 · Mallinckrodt Group, Inc. · Dec 1990
HUGH YOUNG II UROLOGICAL X-RAY SYSTEM
K904147 · Mallinckrodt Group, Inc. · Dec 1990
RADIOPAQUE RULER
K902606 · Professional Medical Services · Sep 1990
SHIMADZU X-RAY HIGH VOLTAGE GENERATOR UD150B
K884477 · Shimadzu Precision Instruments, Inc. · Mar 1989
MEDRAD OMNIPLANE 300 SYSTEM
K883834 · Medrad, Inc. · Nov 1988
MTX GENERATOR
K880352 · Philips Medical Systems (Cleveland), Inc. · Jul 1988