Cleared Traditional

K822775 - INFUS. SETS-9120-50 CM & 9121-100 CM

K822775 is the FDA 510(k) clearance for INFUS. SETS-9120-50 CM & 9121-100 CM by Cardiac Pacemakers, Inc.. It is a Class 2 General Hospital device (product code FPA) cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K822775 · Cardiac Pacemakers, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1982
Decision
50d
Days
Class 2
Risk

K822775 is an FDA 510(k) clearance for the INFUS. SETS-9120-50 CM & 9121-100 CM,EXT. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Cardiac Pacemakers, Inc.. The FDA issued a Cleared decision on November 3, 1982 after a review of 50 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 Cardiac Pacemakers, Inc. devices

Submission Details

510(k) Number K822775 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 14, 1982
Decision Date November 03, 1982
Days to Decision 50 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
79d faster than avg
Panel avg: 129d · This submission: 50d
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 390
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K822775.
SPECIALTY SET MODEL IV7A01
K830891 · Valleylab, Inc. · Apr 1983
MINILOOP I.V. CONNECTORS & ADAPTOR
K830152 · Medex, Inc. · Feb 1983
MINILOOP DISPOS. IV CONNECTORS ADAPT.
K830178 · Medex, Inc. · Feb 1983
DISPOSABLE PLASTIC TRANSFUS./INFUS. ASSB
K822354 · Valleylab, Inc. · Sep 1982
DESERET E-Z SET INFUSION SET
K821750 · Warner-Lambert Co. · Jul 1982
VENOSET DUAL-RATE PIGGYBACK W/IVEX &
K821578 · Abbott Laboratories · Jun 1982