Cleared Traditional

K941731 - EMPTY

K941731 is the FDA 510(k) clearance for EMPTY by Incutech, Inc.. It is a Class 2 General Hospital device (product code KPE) cleared through the Traditional 510(k) pathway after a 106-day FDA review.

K941731 · Incutech, Inc. · General Hospital
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Jul 1994
Decision
106d
Days
Class 2
Risk

K941731 is an FDA 510(k) clearance for the EMPTY, SOLUTION TRANSFER CONTAINER WITH DETATCHABLE LEG SET. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Incutech, Inc. (Greensboro, US). The FDA issued a Cleared decision on July 22, 1994 after a review of 106 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5025 - the FDA general hospital device 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 General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Incutech, Inc. devices

Submission Details

510(k) Number K941731 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 07, 1994
Decision Date July 22, 1994
Days to Decision 106 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
23d faster than avg
Panel avg: 129d · This submission: 106d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code KPE Container, I.v.
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5025
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 General Hospital devices follow this clearance model.

Regulatory Peers - KPE Container, I.v.

All 30
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K941731.
ALL-IN-ONE CONTAINER CAT#'S 2B8114,2B8124, 2B8134, 2B8144, 2B8102, 2B8152, 2B8112, 2B8117M 2B8122, 2B8132, 2B8142, 2B712
K983294 · Baxter Healthcare Corp · Nov 1998
INTRAVIA CONTAINER, EMPTY
K964853 · Baxter Healthcare Corp · Mar 1997
ALL-IN-ONE TWO CHAMBER CONTAINER
K945193 · Baxter Healthcare Corp · May 1995
UNIMIX CONAINER-EMPTY CONTAINER W/3 LEAD TRANS.SET
K932477 · Baxter Healthcare Corp · Jun 1994
EMPTY VIAFLEX PLASTIC CONTAINER
K922214 · Baxter Healthcare Corp · Mar 1993
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
K883400 · Abbott Laboratories · Dec 1989