Cleared Traditional

K944041 - PERSONAL HEARING SYSTEM

K944041 is an FDA 510(k) clearance for PERSONAL HEARING SYSTEM, manufactured by Resound Corp.. The device is a Class 2 General & Plastic Surgery device with product code LRS cleared through the Traditional 510(k) pathway after a 131-day FDA review.

K944041 · Resound Corp. · General & Plastic Surgery device
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Dec 1994
Decision
131d
Days
Class 2
Risk

K944041 is an FDA 510(k) clearance for the PERSONAL HEARING SYSTEM. Classified as I.v. Start Kit (product code LRS), Class II - Special Controls.

Submitted by Resound Corp. (Redwood City, US). The FDA issued a Cleared decision on December 27, 1994 after a review of 131 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5200 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Resound Corp. devices

FDA 510(k) Submission Details - K944041

510(k) Number K944041 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 18, 1994
Decision Date December 27, 1994
Days to Decision 131 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 115d · This submission: 131d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

LRS Device Classification - Class 2, Special Controls

Product Code LRS I.v. Start Kit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
Definition This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. This Type Of Convenience Kit, As Listed In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market If It Meets All Criteria In The Guidance.
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - LRS I.v. Start Kit

All 16
Devices cleared under the same product code (LRS) and FDA review panel - the closest regulatory comparables to K944041.
AMSINO I.V. START KIT
K050654 · Amsino International, Inc. · May 2005
IV START KIT
K963722 · Grand Medical Products · Nov 1996
B. BRAUN IV START KITS
K950184 · B. Braun of America, Inc. · Mar 1995
SAFESTART VASCULAR ACCESS START KIT
K943941 · Becton Dickinson Vascular Access, Inc. · Oct 1994
IV START KIT
K935684 · Cush Medical Products · Jun 1994
I.V. STARTPAK VASCULAR ACCESS START KIT
K942238 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1994