Cleared Traditional

K822776 - TEFLON CANNULA

K822776 is an FDA 510(k) clearance for TEFLON CANNULA, manufactured by Cardiac Pacemakers, Inc.. The device is a Class 2 General Hospital device with product code FOZ cleared through the Traditional 510(k) pathway after a 50-day FDA review.

K822776 · Cardiac Pacemakers, Inc. · General Hospital
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Nov 1982
Decision
50d
Days
Class 2
Risk

K822776 is an FDA 510(k) clearance for the TEFLON CANNULA. Classified as Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days (product code FOZ), 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 880.5200 - 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.

FDA 510(k) Submission Details - K822776

510(k) Number K822776 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.

FOZ Device Classification - Class 2, Special Controls

Product Code FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5200
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 - FOZ Catheter, Intravascular, Therapeutic, Short-term Less Than 30 Days

All 492
Devices cleared under the same product code (FOZ) and FDA review panel - the closest regulatory comparables to K822776.
INTRAVASCULAR CATHETER SET
K830539 · Lab-A-Cath Corp. · Mar 1983
MULTI-LUMEN INTRAVENOUS CATHETER
K823565 · Mcpherson Enterprises, Inc. · Dec 1982
CENTRAL VENOUS CATHETER
K823351 · Plasmedics, Inc. · Dec 1982
INTRAVENOUS CATHETER PLACEMENT UNIT &
K823017 · Access Devices, Inc. · Nov 1982
DESERET SUBCLAVIAN JUGULAR CATH. SET
K822023 · Warner-Lambert Co. · Jul 1982
SUBCLAVIAN
K821929 · Dna Medical, Inc. · Jul 1982
K822776 · TEFLON CANNULA
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