Cleared Traditional

AUTO-SYRINGE INFUSION SET (K781036) - FDA 510(k) Clearance

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

K781036 · Baxter Healthcare Corp · General Hospital

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Aug 1978

Decision

52d

Days

Class 2

Risk

K781036 is an FDA 510(k) clearance for the AUTO-SYRINGE INFUSION SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Baxter Healthcare Corp (Mchenry, US). The FDA issued a Cleared decision on August 10, 1978 after a review of 52 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 Baxter Healthcare Corp devices

Submission Details

510(k) Number	K781036 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 19, 1978
Decision Date	August 10, 1978
Days to Decision	52 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

77d faster than avg

Panel avg: 129d · This submission: 52d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

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 207

Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K781036.

SOLUTION ADMINISTRATION, TIP PROTECTOR

K781813 · Travenol Laboratories, S.A. · Jan 1979

FILTER FOR HYPERALIMENTATION SET

K782134 · Travenol Laboratories, S.A. · Jan 1979

SOLUTION ADMINISTRATION, FLEX VALVE

K781812 · Travenol Laboratories, S.A. · Dec 1978

BURETTE SET WITH AIR CONTROL LEVER

K780970 · Travenol Laboratories, S.A. · Jul 1978

I.V. LEVER CLAMP

K780481 · Travenol Laboratories, S.A. · Apr 1978

IN-LINE BURETTE SET

K772036 · Abbott Laboratories · Nov 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 K781036

Baxter Healthcare Corp

Mchenry, IL · US

Regulatory profile

505 submissions 496 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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