Cleared Traditional

PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET (K914792) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K914792 · Filtertek, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1992
Decision
84d
Days
Class 2
Risk

K914792 is an FDA 510(k) clearance for the PN 62290 0.22 MICRON MICRO INFUS I.V. EXTEN SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Filtertek, Inc. (Hebron, US). The FDA issued a Cleared decision on January 15, 1992 after a review of 84 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 Filtertek, Inc. devices

Submission Details

510(k) Number K914792 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 23, 1991
Decision Date January 15, 1992
Days to Decision 84 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
45d faster than avg
Panel avg: 129d · This submission: 84d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 208
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K914792.
INJECTION SITE WITH LUER LOCK
K915828 · Baxter Healthcare Corp · May 1992
8000 SERIES VOLUMETRIC PUMP NON-GRAVITY FLOW SET
K920694 · Baxter Healthcare Corp · Mar 1992
3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES
K915390 · Baxter Healthcare Corp · Mar 1992
NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE
K914048 · Baxter Healthcare Corp · Nov 1991
8000 SERIES VOLUMETRIC PUMP SOLUTION SET
K914074 · Baxter Healthcare Corp · Oct 1991
3 PORT ADAPTER
K913627 · Baxter Healthcare Corp · Sep 1991