Cleared Traditional

K841443 - REDO CENTRAL VENOUS CATHETER-NEONATE

K841443 is the FDA 510(k) clearance for REDO CENTRAL VENOUS CATHETER-NEONATE by Intl. Hospital Products, Inc.. It is a Class 2 General Hospital device (product code LJS) cleared through the Traditional 510(k) pathway after a 112-day FDA review.

K841443 · Intl. Hospital Products, Inc. · General Hospital
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Jul 1984
Decision
112d
Days
Class 2
Risk

K841443 is an FDA 510(k) clearance for the REDO CENTRAL VENOUS CATHETER-NEONATE. Classified as Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days (product code LJS), Class II - Special Controls.

Submitted by Intl. Hospital Products, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 27, 1984 after a review of 112 days - within the typical 510(k) review window.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5970 - 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 Intl. Hospital Products, Inc. devices

Submission Details

510(k) Number K841443 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 06, 1984
Decision Date July 27, 1984
Days to Decision 112 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
17d faster than avg
Panel avg: 129d · This submission: 112d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5970
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 - LJS Catheter, Intravascular, Therapeutic, Long-term Greater Than 30 Days

All 190
Devices cleared under the same product code (LJS) and FDA review panel - the closest regulatory comparables to K841443.
VASCULAR ACCESS CATHETER
K851195 · Sil-Med Corp. · Jun 1985
ARROW-GEISS PERCUTANEOUS TPN KIT
K844080 · Arrow Intl., Inc. · Apr 1985
ARGYLE SILICONE CENTRAL VENOUS CATH-
K843450 · Sherwood Medical Co. · Nov 1984
RIGHT ATRIAL CATHETER
K840742 · The Healthcare Group Laboratories, Inc. · Jul 1984
SHEATH REMOVER
K841878 · Datascope Corp. · Jul 1984
LONG TERM CENTRAL VENOUS ACCESS CATH
K834299 · Burron Medical Products, Inc. · May 1984