Cleared Traditional

6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT (K980127) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K980127 · Catheter Innovations, Inc. · General Hospital
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Mar 1998
Decision
56d
Days
Class 2
Risk

K980127 is an FDA 510(k) clearance for the 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENS.... Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Catheter Innovations, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 11, 1998 after a review of 56 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Catheter Innovations, Inc. devices

Submission Details

510(k) Number K980127 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 14, 1998
Decision Date March 11, 1998
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code FPA Set, Administration, Intravascular
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPA Set, Administration, Intravascular

All 208
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K980127.
SOLUTION ADMINISTRATION SET
K981792 · Baxter Healthcare Corp · Aug 1998
SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE
K974571 · Baxter Healthcare Corp · May 1998
DUAL LUER LOCK CAP
K981318 · Baxter Healthcare Corp · Apr 1998
CONTINU-FLO SOLUTION SET
K971701 · Baxter Healthcare Corp · Jun 1997
INTERLINK MICRO-INFUSION MANIFOLD EXTENSION SETS
K970438 · Baxter Healthcare Corp · Apr 1997
SOLUTION ADMINISTRATION SET WITH 0.22 MICRON HIGH PRESSURE EXTENDED LIFE FILTER
K964850 · Baxter Healthcare Corp · Feb 1997