Cleared Traditional

K864015 - STERILABELS

K864015 · Diversatronics, Inc. · General & Plastic Surgery device
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Dec 1986
Decision
58d
Days
-
Risk

K864015 is an FDA 510(k) clearance for the STERILABELS.

Submitted by Diversatronics, Inc. (Broomall, US). The FDA issued a Cleared decision on December 12, 1986 after a review of 58 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 Diversatronics, Inc. devices

FDA 510(k) Submission Details - K864015

510(k) Number K864015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 1986
Decision Date December 12, 1986
Days to Decision 58 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
57d faster than avg
Panel avg: 115d · This submission: 58d
Pathway characteristics
Predicate-based equivalence.

LDQ Device Classification - Class ,

Product Code LDQ
Device Class -

Regulatory Peers - LDQ

All 40
Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K864015.
GLOVE LEAK DETECTOR
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K874186 · Busse Hospital Disposables, Inc. · Dec 1987
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