Cleared Traditional

K993962 - PENSIL TRAUMA, MODEL WWS6100

K993962 is an FDA 510(k) clearance for PENSIL TRAUMA, manufactured by Wuestec Medical, Inc.. The device is a Class 2 Radiology device with product code KPR cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K993962 · Wuestec Medical, Inc. · Radiology device
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Dec 1999
Decision
57d
Days
Class 2
Risk

K993962 is an FDA 510(k) clearance for the PENSIL TRAUMA, MODEL WWS6100. Classified as System, X-ray, Stationary (product code KPR), Class II - Special Controls.

Submitted by Wuestec Medical, Inc. (Mobile, US). The FDA issued a Cleared decision on December 21, 1999 after a review of 57 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 Wuestec Medical, Inc. devices

FDA 510(k) Submission Details - K993962

510(k) Number K993962 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 25, 1999
Decision Date December 21, 1999
Days to Decision 57 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
50d faster than avg
Panel avg: 107d · This submission: 57d
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 220
Devices cleared under the same product code (KPR) and FDA review panel - the closest regulatory comparables to K993962.
DR9000 DIGITAL RADIOGRAPHY X-RAY SYSTEM
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K001201 · Siemens Medical Solutions USA, Inc. · Jun 2000
LEGEND CRF FLUORO AND RAD SYSTEM
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SILHOUETTE FC
K993090 · Ge Medical Systems, Inc. · Oct 1999
REVOLUTION TX/I DIGITAL RADIOGRAPHIC TABLE SYSTEM
K992066 · GE Medical Systems · Aug 1999