Cleared Traditional

K892052 - SARNS MEDICAL CART

K892052 · 3M Company · General & Plastic Surgery device

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Jun 1989

Decision

78d

Days

Risk

K892052 is an FDA 510(k) clearance for the SARNS MEDICAL CART.

Submitted by 3M Company (Ann Arbor, US). The FDA issued a Cleared decision on June 15, 1989 after a review of 78 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.

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Submission Details

510(k) Number	K892052 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 29, 1989
Decision Date	June 15, 1989
Days to Decision	78 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

37d faster than avg

Panel avg: 115d · This submission: 78d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	LDQ
Device Class	-

Regulatory Peers - LDQ

All 16

Devices cleared under the same product code (LDQ) and FDA review panel - the closest regulatory comparables to K892052.

OLYMPIC WARMETTE

K911955 · Olympic Medical Corp. · Jul 1991

GLOVE LEAK DETECTOR

K901237 · Utah Medical Products, Inc. · Aug 1990

DISPOS. POLY APRONS

K842016 · Abco Dealers, Inc. · Jul 1984

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

Related FDA 510(k) Regulatory Insights

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

Manufacturer of K892052

3M Company

Ann Arbor, MI · US

CATHY L SIMPSON

Regulatory profile

331 submissions 322 cleared

97% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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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 . Updated monthly.

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