Cleared Traditional

K980127 - 6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT

K980127 is an FDA 510(k) clearance for 6 INCH MINI-BONE EXTENSION SET WITH LUE..., manufactured by Catheter Innovations, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 56-day FDA review.

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

FDA 510(k) Submission Details - K980127

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
Combination Product No
PCCP Authorized No
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.

FPA Device Classification - Class 2, Special Controls

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 657
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K980127.
SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE
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K980583 · Sims Deltec, Inc. · Apr 1998
DUAL LUER LOCK CAP
K981318 · Baxter Healthcare Corp · Apr 1998
NP MEDICAL CAPLESS LUER ACTIVATED VALVE
K973916 · Np Medical, Inc. · Mar 1998
MINIMED SOF-SET ULTIMATE QR INFUSION SET MODELS 315 AND 316
K974163 · Medtronic Minimed · Feb 1998
MCKINLEY OUTBOUND-2 SYSTEM
K971844 · Mckinley, Inc. · Jan 1998