Cleared Traditional

K974571 - SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE

K974571 is an FDA 510(k) clearance for SOLUTION ADMINISTRATION SET WITH CAPPED..., manufactured by Baxter Healthcare Corp. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 164-day FDA review.

K974571 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 1998
Decision
164d
Days
Class 2
Risk

K974571 is an FDA 510(k) clearance for the SOLUTION ADMINISTRATION SET WITH CAPPED LUER ACTIVATED VALVE. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Round Lake, US). The FDA issued a Cleared decision on May 21, 1998 after a review of 164 days - an extended review 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: 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 Baxter Healthcare Corp devices

FDA 510(k) Submission Details - K974571

510(k) Number K974571 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 08, 1997
Decision Date May 21, 1998
Days to Decision 164 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
35d slower than avg
Panel avg: 129d · This submission: 164d
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 791
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K974571.
STABLE FLOW
K981157 · Cmed · Jun 1998
IV ADMINISTRATION SETS WITH NEEDLE ACCESS DEVICES
K980994 · Venetec Intl., Inc. · May 1998
IV ADMINISTRATION SETS WITH NEEDLELESS ACCESS DEVICES
K980992 · Venetec Intl., Inc. · May 1998
EXTENSION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE CADD ADMINISTRATION SET WITH 0.2U FILTER AND ANTI-SIPHON VALVE
K980583 · Sims Deltec, Inc. · Apr 1998
DUAL LUER LOCK CAP
K981318 · Baxter Healthcare Corp · Apr 1998
6 INCH MINI-BONE EXTENSION SET WITH LUER LOCK, NES01S, 6 INCH MIN-BONE EXTENSION SET WITH LUER SLIP, NES02S, 6 INCH STAT
K980127 · Catheter Innovations, Inc. · Mar 1998