Cleared Traditional

K822406 - BOSTON SOLUTION INFUSION SETS

K822406 is the FDA 510(k) clearance for BOSTON SOLUTION INFUSION SETS by The Boston Medical Group. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K822406 · The Boston Medical Group · General Hospital
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Sep 1982
Decision
51d
Days
Class 2
Risk

K822406 is an FDA 510(k) clearance for the BOSTON SOLUTION INFUSION SETS. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by The Boston Medical Group (Walker, US). The FDA issued a Cleared decision on September 30, 1982 after a review of 51 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 The Boston Medical Group devices

Submission Details

510(k) Number K822406 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1982
Decision Date September 30, 1982
Days to Decision 51 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
78d faster than avg
Panel avg: 129d · This submission: 51d
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 481
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K822406.
MACRODOT ADD-I-MED ADMIN. SET
K823347 · Imed Corp. · Nov 1982
ACCUDOT 380 SECONDARY I.V. SET
K823027 · Imed Corp. · Nov 1982
INFUS. SETS-9120-50 CM & 9121-100 CM,EXT
K822775 · Cardiac Pacemakers, Inc. · Nov 1982
DISPOSABLE PLASTIC TRANSFUS./INFUS. ASSB
K822354 · Valleylab, Inc. · Sep 1982
AS 700 SERIES INFUSION PUMP ADMIN.
K821377 · Narco Scientific · Jul 1982
DESERET E-Z SET INFUSION SET
K821750 · Warner-Lambert Co. · Jul 1982