Cleared Traditional

K011514 - INSTRUMENTS FOR ONE TIME USE - DISPOSABLE

K011514 is an FDA 510(k) clearance for INSTRUMENTS FOR ONE TIME USE - DISPOSABLE, manufactured by Kencap , Ltd.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K011514 · Kencap , Ltd. · General & Plastic Surgery device
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Aug 2001
Decision
88d
Days
Class 1
Risk

K011514 is an FDA 510(k) clearance for the INSTRUMENTS FOR ONE TIME USE - DISPOSABLE. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by Kencap , Ltd. (Ringwood, US). The FDA issued a Cleared decision on August 13, 2001 after a review of 88 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 Kencap , Ltd. devices

FDA 510(k) Submission Details - K011514

510(k) Number K011514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 17, 2001
Decision Date August 13, 2001
Days to Decision 88 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
27d faster than avg
Panel avg: 115d · This submission: 88d
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 K011514.
CONVENIENCE KIT FOR SINGLE-INCISION LAPAROSCOPIC SURGERY AND OTHER ADVANCED LAPAROSCOPIC PROCEDURES
K072814 · Covidien · Apr 2008
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K971317 · National Healthcare Mfg. Corp. · May 1997
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