Cleared Traditional

K780604 - SHAVE PREP

K780604 is an FDA 510(k) clearance for SHAVE PREP, manufactured by Abco Dealers, Inc.. The device is a Class 1 General Hospital device with product code KXF cleared through the Traditional 510(k) pathway after a 9-day FDA review.

K780604 · Abco Dealers, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1978
Decision
9d
Days
Class 1
Risk

K780604 is an FDA 510(k) clearance for the SHAVE PREP. Classified as Applicator, Absorbent Tipped, Non-sterile (product code KXF), Class I - General Controls.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 19, 1978 after a review of 9 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6025 - the FDA general hospital 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 - K780604

510(k) Number K780604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1978
Decision Date April 19, 1978
Days to Decision 9 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
120d faster than avg
Panel avg: 129d · This submission: 9d
Pathway characteristics
Predicate-based equivalence.

KXF Device Classification - Class 1, General Controls

Product Code KXF Applicator, Absorbent Tipped, Non-sterile
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 880.6025
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 - KXF Applicator, Absorbent Tipped, Non-sterile

All 20
Devices cleared under the same product code (KXF) and FDA review panel - the closest regulatory comparables to K780604.
DEXIDE DISPOSABLE PREP STICK
K791168 · Dexide, Inc. · Jul 1979
DEXIDE DISPOSABLE SWAB STICK
K791169 · Dexide, Inc. · Jul 1979
COTTON TIPPED POINT
K780929 · Young Dental Manufacturing Co. 1, LLC · Jun 1978
SEXUAL ASSAULT FORENCIC EVIDENCE KIT
K772298 · Simpson/Basye, Inc. · Mar 1978
CATH KIT, SUPERPUBIC
K772227 · American Hospital Supply Corp. · Dec 1977
MEDI-PAK LEMON GLYCEOIN SWABS
K770583 · General Medical Co. · May 1977
K780604 · SHAVE PREP
Download PDF Abco Dealers, Inc.