Cleared Traditional

K923448 - EMPTY SOLUTION TRANSFER CONTAINER W/ DE...

K923448 is an FDA 510(k) clearance for EMPTY SOLUTION TRANSFER CONTAINER W/ DE..., manufactured by Healthtek, Inc.. The device is a Class 2 General Hospital device with product code KPE cleared through the Traditional 510(k) pathway after a 379-day FDA review.

K923448 · Healthtek, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1993
Decision
379d
Days
Class 2
Risk

K923448 is an FDA 510(k) clearance for the EMPTY SOLUTION TRANSFER CONTAINER W/ DETACH LEG. Classified as Container, I.v. (product code KPE), Class II - Special Controls.

Submitted by Healthtek, Inc. (Auburn, US). The FDA issued a Cleared decision on July 28, 1993 after a review of 379 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Healthtek, Inc. devices

FDA 510(k) Submission Details - K923448

510(k) Number K923448 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 14, 1992
Decision Date July 28, 1993
Days to Decision 379 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
250d slower than avg
Panel avg: 129d · This submission: 379d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

KPE Device Classification - Class 2, Special Controls

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 46
Devices cleared under the same product code (KPE) and FDA review panel - the closest regulatory comparables to K923448.
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
DISPOSABLE BAG DECANTER
K934179 · Byron Medical · May 1994
EMPTY VIAFLEX PLASTIC CONTAINER
K922214 · Baxter Healthcare Corp · Mar 1993
OPTUM(TM) AUTOMATED PATIENT ASSIST DEVICE
K883400 · Abbott Laboratories · Dec 1989
CHURCHILL PARENTERAL NUTRITION BAG - EVA
K870395 · Churchill Corp. · Oct 1987