Cleared Traditional

K834062 - STERILE LABELS

K834062 · Devon Industries, Inc. · General & Plastic Surgery device
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Feb 1984
Decision
71d
Days
-
Risk

K834062 is an FDA 510(k) clearance for the STERILE LABELS.

Submitted by Devon Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on February 4, 1984 after a review of 71 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 Devon Industries, Inc. devices

FDA 510(k) Submission Details - K834062

510(k) Number K834062 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1983
Decision Date February 04, 1984
Days to Decision 71 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
44d faster than avg
Panel avg: 115d · This submission: 71d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 39
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K834062.
SAFETY PINS, ELASTIC BANDAGES & STOCKINETTES
K863633 · Biological & Environmental Control Laboratories · Oct 1986
STERILE GENERAL HOSPITAL SUPPLIES
K851390 · Biological & Environmental Control Laboratories · May 1985
DISPOS. POLY APRONS
K842016 · Abco Dealers, Inc. · Jul 1984
STERILE RUBBER BANDS
K834063 · Devon Industries, Inc. · Dec 1983
TOURNIQUET CUFF PRESSURE MONITOR #TCPM
K832272 · Electromedics, Inc. · Nov 1983
PLASTIC DISPOSABLE RAZOR
K831799 · I M, Inc. · Jul 1983