Cleared Traditional

K842016 - DISPOS. POLY APRONS

K842016 · Abco Dealers, Inc. · General & Plastic Surgery device

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Jul 1984

Decision

46d

Days

Risk

K842016 is an FDA 510(k) clearance for the DISPOS. POLY APRONS.

Submitted by Abco Dealers, Inc. (Mchenry, US). The FDA issued a Cleared decision on July 3, 1984 after a review of 46 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 Abco Dealers, Inc. devices

FDA 510(k) Submission Details - K842016

510(k) Number	K842016 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 18, 1984
Decision Date	July 03, 1984
Days to Decision	46 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

69d faster than avg

Panel avg: 115d · This submission: 46d

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 K842016.

BOWL, SPONGE, DISPOSABLE, STERILE & NON-STERILE

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

STERILE LABELS

K834062 · Devon Industries, Inc. · Feb 1984

STERILE RUBBER BANDS

K834063 · Devon Industries, Inc. · Dec 1983

TOURNIQUET CUFF PRESSURE MONITOR #TCPM

K832272 · Electromedics, Inc. · Nov 1983

FDA 510(k) Resources - General & Plastic Surgery

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K842016

Abco Dealers, Inc.

Mchenry, IL · US

Regulatory profile

127 submissions 127 cleared

100% clearance rate · Active in General & Plastic Surgery

About This 510(k) Record

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . FDA decision: July 3, 1984. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: July 2026.

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