Cleared Traditional

K001424 - KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD

K001424 is an FDA 510(k) clearance for KAWASUMI LABORATORIES IV ADMINISTRATION SET, manufactured by Kawasumi Laboratories America, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K001424 · Kawasumi Laboratories America, Inc. · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2000
Decision
77d
Days
Class 2
Risk

K001424 is an FDA 510(k) clearance for the KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Kawasumi Laboratories America, Inc. (Tampa, US). The FDA issued a Cleared decision on July 21, 2000 after a review of 77 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.

FDA 510(k) Submission Details - K001424

510(k) Number K001424 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2000
Decision Date July 21, 2000
Days to Decision 77 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 129d · This submission: 77d
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 1173
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K001424.
MASTERSITE NEEDLELESS LUER ACTIVATED IV CONNECTOR, MODEL MS 1000
K001106 · Creative Plastic Technology · Aug 2000
LIFESHIELD ADDITIVE PIERCING PIN
K002006 · Abbott Laboratories · Aug 2000
KAWASUMI LABORATORIES IV ADMINISTRATION SET, PRIMARY
K001423 · Kawasumi Laboratories America, Inc. · Jul 2000
KAWASUMI LABORATORIES IV ADMINISTRATION SET WITH FILTER
K001426 · Kawasumi Laboratories America, Inc. · Jul 2000
SURGEN VALVE
K990331 · Tiva Medical · May 2000
POSI-LINK
K000472 · Icu Medical, Inc. · May 2000
K001424 · KAWASUMI LABORATORIES IV ADMINISTRATION SET, STANDARD
Download PDF FDA Summary Kawasumi Laboratories…