Cleared Traditional

K840212 - CONCENTRATED PLATELET ADMIN. SET

K840212 is an FDA 510(k) clearance for CONCENTRATED PLATELET ADMIN. SET, manufactured by American Mcgaw. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 47-day FDA review.

K840212 · American Mcgaw · General Hospital
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Mar 1984
Decision
47d
Days
Class 2
Risk

K840212 is an FDA 510(k) clearance for the CONCENTRATED PLATELET ADMIN. SET. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by American Mcgaw (Mchenry, US). The FDA issued a Cleared decision on March 6, 1984 after a review of 47 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 American Mcgaw devices

FDA 510(k) Submission Details - K840212

510(k) Number K840212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 19, 1984
Decision Date March 06, 1984
Days to Decision 47 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d faster than avg
Panel avg: 129d · This submission: 47d
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 807
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K840212.
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K840760 · C.R. Bard, Inc. · Apr 1984
QUIK LOK
K840878 · Abbott Laboratories · Mar 1984
LOPEZ LOCK
K840273 · Icu Medical, Inc. · Mar 1984
NITROGLYCERIN I.V. ADMINISTRATION SET
K833939 · Critikon Company, LLC · Feb 1984
INTRAVENOUS FILTER SET
K834130 · Tri-Med, Inc. · Jan 1984