Cleared Traditional

BIOGUARD INFUSION LINE FILTER (K791822) - FDA 510(k) Clearance

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

K791822 · United States Surgical, A Division of Tyco Healthc · General Hospital
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Nov 1979
Decision
60d
Days
Class 2
Risk

K791822 is an FDA 510(k) clearance for the BIOGUARD INFUSION LINE FILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by United States Surgical, A Division of Tyco Healthc (Walker, US). The FDA issued a Cleared decision on November 13, 1979 after a review of 60 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 United States Surgical, A Division of Tyco Healthc devices

Submission Details

510(k) Number K791822 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1979
Decision Date November 13, 1979
Days to Decision 60 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
69d faster than avg
Panel avg: 129d · This submission: 60d
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 25
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K791822.
IVEX-HP PEDIATRIC EXTENSION SET-SL
K821013 · Abbott Laboratories · Jul 1982
TERFUSION FINAL FILTER SET
K810113 · Terumo Medical Corp. · Mar 1981
B-D FILTER NEEDLE
K801343 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1980
FILTERSET W/Y-INJECTION SITE, 0.2
K772312 · Abbott Laboratories · Jan 1978
5UM FILTERSET WITH Y-INJECTION SITE
K771972 · Abbott Laboratories · Jan 1978
PRIMARY PIGGYBACK VENOSET W/ FILTER
K771594 · Abbott Laboratories · Sep 1977