Cleared Traditional

LEE BONE MARROW BIOPSY/ASPIRATION TRAY (K852897) - FDA 510(k) Clearance

Class I General & Plastic Surgery device.

K852897 · Southland Instruments, Inc. · General & Plastic Surgery device

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Aug 1985

Decision

43d

Days

Class 1

Risk

K852897 is an FDA 510(k) clearance for the LEE BONE MARROW BIOPSY/ASPIRATION TRAY. Classified as Needle, Aspiration And Injection, Disposable (product code GAA), Class I - General Controls.

Submitted by Southland Instruments, Inc. (Minneapolis, US). The FDA issued a Cleared decision on August 21, 1985 after a review of 43 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4800 - the FDA general and plastic surgery device framework. 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 Southland Instruments, Inc. devices

Submission Details

510(k) Number	K852897 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Direct De Novo (SESD)
Date Received	July 09, 1985
Decision Date	August 21, 1985
Days to Decision	43 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

72d faster than avg

Panel avg: 115d · This submission: 43d

Pathway characteristics

Predicate-based equivalence.

Device Classification

Product Code	GAA Needle, Aspiration And Injection, Disposable
Device Class	Class 1 - General Controls
CFR Regulation	21 CFR 878.4800

What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - GAA Needle, Aspiration And Injection, Disposable

All 10

Devices cleared under the same product code (GAA) and FDA review panel - the closest regulatory comparables to K852897.

MONOJECT BONE MARROW BIOPSY TRAYS

K945109 · Sherwood Medical Co. · Nov 1994

WILSON-COOK LUNG BIOPSY NEEDLE

K897050 · Wilson-Cook Medical, Inc. · Apr 1990

MODIFIED INTENDED USE OF MONOJECT BONE MARROW NEED

K883014 · Sherwood Medical Co. · Jul 1988

HAWKIN NEEDLE

K851953 · Wilson-Cook Medical, Inc. · May 1985

CHIBA NEEDLE

K851957 · Wilson-Cook Medical, Inc. · May 1985

TRU-CUT BIOPSY/ASPIRA-NEEDLE 2N2709

K831392 · Travenol Laboratories, S.A. · Jul 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 K852897

Southland Instruments, Inc.

Minneapolis, MN · US

EDWARD N LEE

Regulatory profile

2 submissions 1 cleared

50% clearance rate · Active in General & Plastic Surgery

Data Intelligence Layer

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 . Updated monthly.

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