Cleared Traditional

K913049 - SLIP-PRUF-CLINGER

K913049 is an FDA 510(k) clearance for SLIP-PRUF-CLINGER, manufactured by Macbrud Corp. Medical Div.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K913049 · Macbrud Corp. Medical Div. · General & Plastic Surgery device
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Sep 1991
Decision
64d
Days
Class 1
Risk

K913049 is an FDA 510(k) clearance for the SLIP-PRUF-CLINGER. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Macbrud Corp. Medical Div. (Miami, US). The FDA issued a Cleared decision on September 11, 1991 after a review of 64 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - 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: 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 Macbrud Corp. Medical Div. devices

FDA 510(k) Submission Details - K913049

510(k) Number K913049 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 1991
Decision Date September 11, 1991
Days to Decision 64 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
51d faster than avg
Panel avg: 115d · This submission: 64d
Pathway characteristics
Predicate-based equivalence.

KDD Device Classification - Class 1, General Controls

Product Code KDD Kit, Surgical Instrument, Disposable
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 878.4800
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 - KDD Kit, Surgical Instrument, Disposable

All 31
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K913049.
SURGICAL INSTRUMENT KIT, DISPOSABLE
K920989 · Ulti-Med Intl., Inc. · Oct 1992
GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB
K920516 · Trinity Laboratories, Inc. · Apr 1992
STERILE CUSTOM SURGICAL KITS
K914244 · Ulti-Med Intl., Inc. · Feb 1992
BAXTER PREOPERATIVE SKIN PREP TRAY W/FOAM SPONGES
K911606 · Baxter Healthcare Corp · Jul 1991
MEGA GENERAL PURPOSE INSTRUMENT KIT
K910366 · Megadyne Medical Products, Inc. · Mar 1991
INCISION AND DRAINAGE KIT
K910369 · Megadyne Medical Products, Inc. · Mar 1991