Cleared Traditional

K834532 - STERILE WET DRESSING PACK

K834532 is an FDA 510(k) clearance for STERILE WET DRESSING PACK, manufactured by W.G. Whitney Corp.. The device is a Class 1 General & Plastic Surgery device with product code KDD cleared through the Traditional 510(k) pathway after a 35-day FDA review.

K834532 · W.G. Whitney Corp. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 1984
Decision
35d
Days
Class 1
Risk

K834532 is an FDA 510(k) clearance for the STERILE WET DRESSING PACK. Classified as Kit, Surgical Instrument, Disposable (product code KDD), Class I - General Controls.

Submitted by W.G. Whitney Corp. (Mchenry, US). The FDA issued a Cleared decision on January 25, 1984 after a review of 35 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 W.G. Whitney Corp. devices

FDA 510(k) Submission Details - K834532

510(k) Number K834532 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1983
Decision Date January 25, 1984
Days to Decision 35 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
80d faster than avg
Panel avg: 115d · This submission: 35d
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 K834532.
STERILE SOLUTION BOWL
K843115 · E.M. Adams · Sep 1984
STERILE SUTURE BOOTS
K834135 · Devon Industries, Inc. · Apr 1984
VYGON THORACIC DRAINAGE-VARIOUS #'S
K832628 · Exco, Inc. · Jan 1984
STERILE DISP. INSTRUMENT TRAYS
K831841 · E.M. Adams · Dec 1983
STERILE SUTURE REMOVAL SET
K832047 · Ormed Mfg., Inc. · Sep 1983
FIRST AID KITS
K831795 · I M, Inc. · Sep 1983