Cleared Traditional

K914244 - STERILE CUSTOM SURGICAL KITS

K914244 is the FDA 510(k) clearance for STERILE CUSTOM SURGICAL KITS by Ulti-Med Intl., Inc.. It is a Class 1 General & Plastic Surgery device (product code KDD) cleared through the Traditional 510(k) pathway after a 154-day FDA review.

K914244 · Ulti-Med Intl., Inc. · General & Plastic Surgery device
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Feb 1992
Decision
154d
Days
Class 1
Risk

K914244 is an FDA 510(k) clearance for the STERILE CUSTOM SURGICAL KITS. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Ulti-Med Intl., Inc. (Glendale Hts., US). The FDA issued a Cleared decision on February 24, 1992 after a review of 154 days - an extended review 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: 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 Ulti-Med Intl., Inc. devices

Submission Details

510(k) Number K914244 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received September 23, 1991
Decision Date February 24, 1992
Days to Decision 154 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
39d slower than avg
Panel avg: 115d · This submission: 154d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 9
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K914244.
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
K072814 · Covidien · Apr 2008
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
C-SECTION TRAY
K842627 · Deroyal Industries, Inc. · Sep 1984
STERILE SUTURE BOOTS
K834135 · Devon Industries, Inc. · Apr 1984