Cleared Traditional

K925905 - KIT, SURGICAL INSTRUMENT, DISPOSABLE

K925905 is an FDA 510(k) clearance for KIT, manufactured by Kay Medical Concepts. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K925905 · Kay Medical Concepts · General & Plastic Surgery device
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Jun 1993
Decision
210d
Days
Class 1
Risk

K925905 is an FDA 510(k) clearance for the KIT, SURGICAL INSTRUMENT, DISPOSABLE. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Kay Medical Concepts (Norcross, US). The FDA issued a Cleared decision on June 16, 1993 after a review of 210 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 Kay Medical Concepts devices

FDA 510(k) Submission Details - K925905

510(k) Number K925905 FDA.gov
FDA Decision Cleared Substantially Equivalent - Special 510(k) (SESK)
Date Received November 18, 1992
Decision Date June 16, 1993
Days to Decision 210 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
95d slower than avg
Panel avg: 115d · This submission: 210d
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 32
Devices cleared under the same product code (KDD) and FDA review panel - the closest regulatory comparables to K925905.
DENVER PARACENTESIS NEEDLE(60-1200) DENVER PARACENTESIS NEEDLE WITH DRAINAGE LINE(60-1100) DENVER PARACENTESIS TRAY
K960456 · Denver Biomaterials, Inc. · Apr 1996
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
SURGICAL INSTRUMENT KIT, DISPOSABLE
K920989 · Ulti-Med Intl., Inc. · Oct 1992
GENERAL PURPOSE INSTRUMENT TRAY, STERILE, DISPOSAB
K920516 · Trinity Laboratories, Inc. · Apr 1992