Cleared Traditional

K914792 - PN 62290 0.22 MICRON MICRO INFUS I.V. E...

K914792 is an FDA 510(k) clearance for PN 62290 0.22 MICRON MICRO INFUS I.V. E..., manufactured by Filtertek, Inc.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 84-day FDA review.

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

FDA 510(k) Submission Details - K914792

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.

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 514
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K914792.
3 LEAD EXTENSION WITH 2 INTERLINK INJECTION SITES
K915390 · Baxter Healthcare Corp · Mar 1992
INJECTION CAP
K913337 · Cp Medical · Feb 1992
ANGIOGRAPHIC FLUSH SYSTEM
K914113 · E-Z-Em, Inc. · Jan 1992
MORSE ANESTHESIA
K905208 · North American Instrument Corp. · Jan 1992
ANGIODYNAMICS ANGIOFILL FLUID MANAGEMENT SYSTEM
K914026 · E-Z-Em, Inc. · Jan 1992
NEEDLE*LOCK(TM) WITH INTERLINK(TM) INJECTION SITE
K914048 · Baxter Healthcare Corp · Nov 1991