Cleared Traditional

K914245 - DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)

K914245 is an FDA 510(k) clearance for DALE NASAL DRESSING HOLDER (PRODUCT NO...., manufactured by Dale Medical Products, Inc.. The device is a Class 1 General & Plastic Surgery device with product code KGX cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K914245 · Dale Medical Products, Inc. · General & Plastic Surgery device
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Dec 1991
Decision
77d
Days
Class 1
Risk

K914245 is an FDA 510(k) clearance for the DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600). Classified as Tape And Bandage, Adhesive (product code KGX), Class I - General Controls.

Submitted by Dale Medical Products, Inc. (Plainville, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 880.5240 - 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.

FDA 510(k) Submission Details - K914245

510(k) Number K914245 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 1991
Decision Date December 09, 1991
Days to Decision 77 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
38d faster than avg
Panel avg: 115d · This submission: 77d
Pathway characteristics
Predicate-based equivalence.

KGX Device Classification - Class 1, General Controls

Product Code KGX Tape And Bandage, Adhesive
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.5240
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 - KGX Tape And Bandage, Adhesive

All 150
Devices cleared under the same product code (KGX) and FDA review panel - the closest regulatory comparables to K914245.
CANN-HOLD
K915057 · O.R. Concepts, Inc. · Mar 1992
OPTICAL CATHETER INTRODUCER SETS, MODIFICATION
K914315 · Medical Dynamics, Inc. · Mar 1992
IMMOBILE
K915565 · Tnt Moborg Intl. , Ltd. · Mar 1992
PROMEON 63B SURGICAL TAPE
K914912 · Promeon · Dec 1991
MEDICAL TAPE
K912623 · Renfrew Tape, Ltd. · Nov 1991
BUTTERFLY DRESSING
K912160 · Durden Enterprises, Inc. · Oct 1991
K914245 · DALE(R) NASAL DRESSING HOLDER (PRODUCT NO. 600)
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