Cleared Traditional

K912848 - I.V. FILTER EXTENSION SET

K912848 is an FDA 510(k) clearance for I.V. FILTER EXTENSION SET, manufactured by Filtertek, Inc.. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K912848 · Filtertek, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
154d
Days
Class 2
Risk

K912848 is an FDA 510(k) clearance for the I.V. FILTER EXTENSION SET. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Filtertek, Inc. (Hebron, US). The FDA issued a Cleared decision on November 29, 1991 after a review of 154 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 Filtertek, Inc. devices

FDA 510(k) Submission Details - K912848

510(k) Number K912848 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 28, 1991
Decision Date November 29, 1991
Days to Decision 154 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
25d slower than avg
Panel avg: 129d · This submission: 154d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPB Device Classification - Class 2, Special Controls

Product Code FPB Filter, Infusion Line
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 - FPB Filter, Infusion Line

All 61
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K912848.
FENWAL 40 MICRON TRANSFUSION FILTER
K931441 · Baxter Healthcare Corp · Sep 1993
IVEX-HP96 EXTENDED LIFE FILTER SET
K920736 · Abbott Laboratories · Apr 1993
IVEX-TPN EXTENSION FILTER SET
K913308 · Abbott Laboratories · Jan 1992
PALL 3N1 FILTER
K905794 · Pall Biomedical Products Co. · Jun 1991
LABELING CHANGE FOR CUTTER PUREFLO PLUS IV FILTER
K880605 · Miles Laboratories, Inc. · May 1988
CHURCHILL 0.22 MICRON LIQUID FILTER SETS
K880025 · Churchill Corp. · Apr 1988