Cleared Traditional

K935157 - ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES

K935157 is an FDA 510(k) clearance for ARTICULATED, manufactured by Regulatory Consultants TO the Medical Device Indus. The device is a Class 2 Radiology device with product code KPX cleared through the Traditional 510(k) pathway after a 285-day FDA review.

K935157 · Regulatory Consultants TO the Medical Device Indus · Radiology device
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Aug 1994
Decision
285d
Days
Class 2
Risk

K935157 is an FDA 510(k) clearance for the ARTICULATED, LAPAROSCOPIC, AND SIDE-VIEWING T-PROBES. Classified as Changer, Radiographic Film/cassette (product code KPX), Class II - Special Controls.

Submitted by Regulatory Consultants TO the Medical Device Indus (Sandy, US). The FDA issued a Cleared decision on August 9, 1994 after a review of 285 days - an extended review cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.1860 - 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.

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FDA 510(k) Submission Details - K935157

510(k) Number K935157 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1993
Decision Date August 09, 1994
Days to Decision 285 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
178d slower than avg
Panel avg: 107d · This submission: 285d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPX Device Classification - Class 2, Special Controls

Product Code KPX Changer, Radiographic Film/cassette
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.1860
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 - KPX Changer, Radiographic Film/cassette

All 13
Devices cleared under the same product code (KPX) and FDA review panel - the closest regulatory comparables to K935157.
TRANS X-1000
K945635 · Canon USA, Inc. · Feb 1995
NUCLEAR ASSOCIATES PERSONNEL PROTECTIVE SHIELDS
K934850 · Victoreen, Inc. · Nov 1993
SHIMADZU RADIOGRAPJHIC STAND BR-100
K925169 · Shimadzu Medical Systems · Dec 1992
DU PONT COMPACT DAYLIGHT SYSTEM 2000
K922483 · E.I. Dupont DE Nemours & Co., Inc. · Sep 1992
FRANKLIN 9000 WALL STAND
K905789 · Mallinckrodt Group, Inc. · May 1991
AUTOMATIC CASSETTE LOADER
K902761 · Mallinckrodt Group, Inc. · Oct 1990