Cleared Traditional

K841443 - REDO CENTRAL VENOUS CATHETER-NEONATE

K841443 is an FDA 510(k) clearance for REDO CENTRAL VENOUS CATHETER-NEONATE, manufactured by Intl. Hospital Products, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K841443

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.

LJS Device Classification - Class 2, Special Controls

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 278
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