Cleared Traditional

K813566 - CARDIO-BAND

K813566 · Cardio-Band, Inc. · General & Plastic Surgery device
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Feb 1982
Decision
62d
Days
-
Risk

K813566 is an FDA 510(k) clearance for the CARDIO-BAND.

Submitted by Cardio-Band, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 22, 1982 after a review of 62 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Cardio-Band, Inc. devices

FDA 510(k) Submission Details - K813566

510(k) Number K813566 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1981
Decision Date February 22, 1982
Days to Decision 62 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
53d faster than avg
Panel avg: 115d · This submission: 62d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 40
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SAFETY PINS
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TRACHEOSTOMY CARE TRAY
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POSTURE MIRROR
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