Cleared Traditional

K931377 - SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT

K931377 is an FDA 510(k) clearance for SAFELINE SYSTEM IV ADMINISTRATION SETS ..., manufactured by Mcgaw, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 354-day FDA review.

K931377 · Mcgaw, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1994
Decision
354d
Days
Class 2
Risk

K931377 is an FDA 510(k) clearance for the SAFELINE SYSTEM IV ADMINISTRATION SETS & COMPONENT. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Mcgaw, Inc. (Irvine, US). The FDA issued a Cleared decision on March 7, 1994 after a review of 354 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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 Mcgaw, Inc. devices

FDA 510(k) Submission Details - K931377

510(k) Number K931377 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 18, 1993
Decision Date March 07, 1994
Days to Decision 354 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
225d slower than avg
Panel avg: 129d · This submission: 354d
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 681
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K931377.
INFUSION ADMINISTRATION SET
K940053 · Puritas Health Care, Inc. · Mar 1994
I.V. SET (20 DROPS/ML)
K940072 · Puritas Health Care, Inc. · Mar 1994
EXTENSION TUBE, EXTENSION TUBE LENGTH 20, & 30
K940073 · Puritas Health Care, Inc. · Mar 1994
SAFE CONNECTOR
K940296 · Icu Medical, Inc. · Feb 1994
REMOTE RESERVOIR ADAPTER(TM) CASSETTE WITH BAG
K933390 · Pharmacia Deltec, Inc. · Feb 1994
0.22 MICRON FINAL FILTER WITH EXTENSION TUBE
K935601 · Puritas Health Care, Inc. · Jan 1994