Cleared Traditional

K922558 - INTERLINK(TM) INJECTION SITE

K922558 is an FDA 510(k) clearance for INTERLINK(TM) INJECTION SITE, 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 144-day FDA review.

K922558 · Baxter Healthcare Corp · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1992
Decision
144d
Days
Class 2
Risk

K922558 is an FDA 510(k) clearance for the INTERLINK(TM) INJECTION SITE. 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 October 19, 1992 after a review of 144 days - within the typical 510(k) review window.

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 - K922558

510(k) Number K922558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 28, 1992
Decision Date October 19, 1992
Days to Decision 144 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
15d slower than avg
Panel avg: 129d · This submission: 144d
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 793
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K922558.
AVI(TM) MODEL 232 STANDARD IV ADMINISTRATION SET
K924207 · 3M Health Care, Ltd. · May 1993
INTERLINK SYSTEM - T-CONNECTOR EXTENSION SET
K921899 · Baxter Healthcare Corp · Apr 1993
LIFESHIELD ANESTHESIA SET
K913982 · Abbott Laboratories · Nov 1992
SUBCUTANEOUS INFUSION SET
K920537 · Marquette Medical, Inc. · Oct 1992
LIFEPORT INFUSION SET AND INFUSION SET W/ Y SITE
K921674 · Strato Medical Corp. · Sep 1992
CLAVE CONNECTOR
K915571 · Icu Medical, Inc. · Sep 1992