Cleared Traditional

K841558 - BANANA CUFF

K841558 is an FDA 510(k) clearance for BANANA CUFF, manufactured by Aspen Laboratories, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KCY cleared through the Traditional 510(k) pathway after a 91-day FDA review.

K841558 · Aspen Laboratories, Inc. · General & Plastic Surgery device
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Jul 1984
Decision
91d
Days
Class 1
Risk

K841558 is an FDA 510(k) clearance for the BANANA CUFF. Classified as Tourniquet, Pneumatic (product code KCY), Class I - General Controls.

Submitted by Aspen Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 16, 1984 after a review of 91 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.5910 - the FDA general and plastic surgery 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Aspen Laboratories, Inc. devices

FDA 510(k) Submission Details - K841558

510(k) Number K841558 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 16, 1984
Decision Date July 16, 1984
Days to Decision 91 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
24d faster than avg
Panel avg: 115d · This submission: 91d
Pathway characteristics
Predicate-based equivalence.

KCY Device Classification - Class 1, General Controls

Product Code KCY Tourniquet, Pneumatic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.5910
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 - KCY Tourniquet, Pneumatic

All 14
Devices cleared under the same product code (KCY) and FDA review panel - the closest regulatory comparables to K841558.
A.T.S. 1500 TOURNIQUET
K870784 · Aspen Laboratories, Inc. · Mar 1987
SINGLE AND DUAL TOURNIQUET CUFF
K860463 · Aspen Laboratories, Inc. · Feb 1986
ATS 500 TOURNIQUET
K853802 · Aspen Laboratories, Inc. · Oct 1985
PRESSURE SENTRY TOURNIQUET
K840206 · Richards Medical Co., Inc. · Apr 1984
TOURNIQUET
K813231 · Aspen Laboratories, Inc. · Dec 1981
TEST PRESSURE GAUGE #6675-32
K791759 · Depuy, Inc. · Oct 1979