Cleared Traditional

PRIMARY PIGGYBACK VENOSET W/ FILTER (K771594) - FDA 510(k) Clearance

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

K771594 · Abbott Laboratories · General Hospital

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Sep 1977

Decision

40d

Days

Class 2

Risk

K771594 is an FDA 510(k) clearance for the PRIMARY PIGGYBACK VENOSET W/ FILTER. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on September 28, 1977 after a review of 40 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 Abbott Laboratories devices

Submission Details

510(k) Number	K771594 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	August 19, 1977
Decision Date	September 28, 1977
Days to Decision	40 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

89d faster than avg

Panel avg: 129d · This submission: 40d

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 K771594.

BIOGUARD INFUSION LINE FILTER

K791822 · United States Surgical, A Division of Tyco Healthc · Nov 1979

FILTERSET W/Y-INJECTION SITE, 0.2

K772312 · Abbott Laboratories · Jan 1978

5UM FILTERSET WITH Y-INJECTION SITE

K771972 · Abbott Laboratories · Jan 1978

CONTINU-FLO Y-TYPE SOLUTION ADMIN. SET

K771498 · Travenol Laboratories, S.A. · Aug 1977

IV PUMP FILTERSET, UNIVERSAL

K770843 · Abbott Laboratories · Jun 1977

0.22/UM FILTERSET W/Y-INJECTION SITE

K770182 · Abbott Laboratories · Mar 1977

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K771594

Abbott Laboratories

Abbott Park, IL · US

Regulatory profile

883 submissions 868 cleared

98% clearance rate · Active in General Hospital

Data Intelligence Layer

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Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

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