Cleared Traditional

K892052 - SARNS MEDICAL CART

K892052 · 3M Company · General & Plastic Surgery device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

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.

FDA 510(k) Submission Details - K892052

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.

LDQ Device Classification - Class ,

Product Code	LDQ
Device Class	-

Regulatory Peers - LDQ

All 79

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

MEDICOOL, CONTAINER FOR STORING INSULIN

K895674 · Medicool, Inc. · Jan 1990

UNIVERSAL LIGHT CABLE

K894570 · Expanded Optics, Inc. · Oct 1989

SIEMENS CEILING STAND 800F, 800 AND 810

K891023 · Siemens Medical Electronics · Jul 1989

INSU COOL

K885055 · Dynex Trading Co. · Apr 1989

MULTI-PURPOSE HOLDER

K884630 · Med-Dex Intl. · Nov 1988

MR. RAZOR II TWIN

K882388 · Burney Products Corp. · Jul 1988

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 K892052

3M Company

Ann Arbor, MI · US

CATHY L SIMPSON

Regulatory profile

331 submissions 322 cleared

97% clearance rate · Active in General & Plastic Surgery

View all devices by 3M Company →

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: June 15, 1989. Record added to 510k Database: March 2026. Enriched with classification and manufacturer data: June 2026.

Verify on FDA.gov

510k Database

510(k) clearances indexed 176,583

Regulatory data since 1976

FDA monthly sync November 6, 2026