Cleared Traditional

K943802 - HP BACK POINTER SYSTEM

K943802 is an FDA 510(k) clearance for HP BACK POINTER SYSTEM, manufactured by Medtec, Inc.. The device is a Class 1 Radiology device with product code IWE cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K943802 · Medtec, Inc. · Radiology device
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Dec 1994
Decision
125d
Days
Class 1
Risk

K943802 is an FDA 510(k) clearance for the HP BACK POINTER SYSTEM. Classified as Monitor, Patient Position, Light-beam (product code IWE), Class I - General Controls.

Submitted by Medtec, Inc. (Orange City, US). The FDA issued a Cleared decision on December 7, 1994 after a review of 125 days - within the typical 510(k) review window.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5780 - 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 Medtec, Inc. devices

FDA 510(k) Submission Details - K943802

510(k) Number K943802 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 04, 1994
Decision Date December 07, 1994
Days to Decision 125 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
18d slower than avg
Panel avg: 107d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

IWE Device Classification - Class 1, General Controls

Product Code IWE Monitor, Patient Position, Light-beam
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 892.5780
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - IWE Monitor, Patient Position, Light-beam

All 11
Devices cleared under the same product code (IWE) and FDA review panel - the closest regulatory comparables to K943802.
GREEN TEC-2100
K955236 · Medtec, Inc. · May 1996
TEC-2110 GREEN LASER MODEL MT-HNG
K950293 · Medtec, Inc. · Aug 1995
MED-TEC STRING RETICLE TRAY
K951601 · Medtec, Inc. · May 1995
LASER ALIGNMENT TOOL
K943381 · Philips Medical Systems North America, Inc. · Aug 1994
TEC 2101 (MODEL MT-HPLGD)
K941169 · Medtec, Inc. · Jul 1994
TEC 2100 (MODEL MT-LPLGD)
K935760 · Medtec, Inc. · Jan 1994