Cleared Traditional

K974661 - 0.2 U BACTERIAL FILTER

K974661 is the FDA 510(k) clearance for 0.2 U BACTERIAL FILTER by Sims Deltec, Inc.. It is a Class 2 General Hospital device (product code FPB) cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K974661 · Sims Deltec, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1998
Decision
58d
Days
Class 2
Risk

K974661 is an FDA 510(k) clearance for the 0.2 U BACTERIAL FILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Sims Deltec, Inc. (St. Paul, US). The FDA issued a Cleared decision on February 11, 1998 after a review of 58 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 Sims Deltec, Inc. devices

Submission Details

510(k) Number K974661 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 15, 1997
Decision Date February 11, 1998
Days to Decision 58 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
71d faster than avg
Panel avg: 129d · This submission: 58d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 53
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K974661.
Filter Needle for Single Use
K233277 · Hangzhou Qiantang Longyue Biotechnology Co., Ltd. · May 2024
NON-DEHP MICRO-VOLUME EXTENSION SET WITH 0.22 MICRON FILTER
K113227 · Baxter Healthcare Corp · Dec 2011
PHARMASSURE LARGE VOLUME TRANSFER FILTERS
K943127 · Gelman Sciences, Inc. · Sep 1994
IVEX-2 EXTENSION SET WITH Y-INJECTION SITE
K941684 · Abbott Laboratories · Aug 1994
VIAL VENT FILTER
K942275 · Gelman Sciences, Inc. · Jul 1994
EXTENSION SET WITH 0.22 MICRON 96 HOUR FILTER
K933869 · Baxter Healthcare Corp · Apr 1994