Cleared Traditional

K800358 - Y-TYPE INFUSION SET (2 LEAD)

K800358 is an FDA 510(k) clearance for Y-TYPE INFUSION SET (2 LEAD), manufactured by Haemonetics Corp.. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K800358 · Haemonetics Corp. · General Hospital
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Apr 1980
Decision
56d
Days
Class 2
Risk

K800358 is an FDA 510(k) clearance for the Y-TYPE INFUSION SET (2 LEAD). Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Haemonetics Corp. (Mchenry, US). The FDA issued a Cleared decision on April 16, 1980 after a review of 56 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 Haemonetics Corp. devices

FDA 510(k) Submission Details - K800358

510(k) Number K800358 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1980
Decision Date April 16, 1980
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

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 532
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K800358.
MCGRAW I.V. ADMINISTRATION SET
K801540 · American Hospital Supply Corp. · Aug 1980
MODEL 72-81-0 UNVENTED SOLUTION ADM. SET
K801613 · Y · Aug 1980
VOLUMETRIC PUMP CASSETTE W/ATTACHED SET
K800711 · Travenol Laboratories, S.A. · May 1980
MCGAW/EPIC I.V. ADMIN. SET
K800403 · American Hospital Supply Corp. · Apr 1980
B-D STASET, I.V. FLOW CONTROLLER
K800600 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1980
LOW PLASTICIZER ADMINISTRATION SETS
K791496 · Travenol Laboratories, S.A. · Apr 1980