Cleared Traditional

K881392 - CARDICAD(TM)

K881392 is an FDA 510(k) clearance for CARDICAD(TM), manufactured by Medical/Surgical Specialties, Ltd.. The device is a Class 1 Cardiovascular device with product code DWS cleared through the Traditional 510(k) pathway after a 57-day FDA review.

K881392 · Medical/Surgical Specialties, Ltd. · Cardiovascular device
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May 1988
Decision
57d
Days
Class 1
Risk

K881392 is an FDA 510(k) clearance for the CARDICAD(TM). Classified as Instruments, Surgical, Cardiovascular (product code DWS), Class I - General Controls.

Submitted by Medical/Surgical Specialties, Ltd. (Kalamazoo, US). The FDA issued a Cleared decision on May 31, 1988 after a review of 57 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.4500 - the FDA cardiovascular device oversight 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 Medical/Surgical Specialties, Ltd. devices

FDA 510(k) Submission Details - K881392

510(k) Number K881392 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1988
Decision Date May 31, 1988
Days to Decision 57 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 125d · This submission: 57d
Pathway characteristics
Predicate-based equivalence.

DWS Device Classification - Class 1, General Controls

Product Code DWS Instruments, Surgical, Cardiovascular
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.4500
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - DWS Instruments, Surgical, Cardiovascular

All 54
Devices cleared under the same product code (DWS) and FDA review panel - the closest regulatory comparables to K881392.
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