Cleared Traditional

K920989 - SURGICAL INSTRUMENT KIT, DISPOSABLE

K920989 is an FDA 510(k) clearance for SURGICAL INSTRUMENT KIT, manufactured by Ulti-Med Intl., Inc.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 231-day FDA review.

K920989 · Ulti-Med Intl., Inc. · General & Plastic Surgery device
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Oct 1992
Decision
231d
Days
Class 1
Risk

K920989 is an FDA 510(k) clearance for the SURGICAL INSTRUMENT KIT, DISPOSABLE. 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 October 19, 1992 after a review of 231 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

FDA 510(k) Submission Details - K920989

510(k) Number K920989 FDA.gov
FDA Decision Cleared Substantially Equivalent - De Novo Granted (SEKD)
Date Received March 02, 1992
Decision Date October 19, 1992
Days to Decision 231 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
116d slower than avg
Panel avg: 115d · This submission: 231d
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 30
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K920989.
SUTURE SET OR LACERATION TRAYS (PACKS)
K932219 · Associated Medical Products Co. · Jul 1993
SURGICAL INSTRUMENT KIT, DISPOSABLE
K923176 · Ulti-Med Intl., Inc. · Jun 1993
DEXIDE LAPAROSCOPIC KITS
K924117 · Dexide, Inc. · Mar 1993
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