Cleared Traditional

K832027 - ARGYLE YANKAVER SUCTION TUBE W/CONTROL

K832027 is the FDA 510(k) clearance for ARGYLE YANKAVER SUCTION TUBE W/CONTROL by Sherwood Medical Co.. It is a Class 2 General Hospital device (product code JOL) cleared through the Traditional 510(k) pathway after a 46-day FDA review.

K832027 · Sherwood Medical Co. · General Hospital

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Aug 1983

Decision

46d

Days

Class 2

Risk

K832027 is an FDA 510(k) clearance for the ARGYLE YANKAVER SUCTION TUBE W/CONTROL. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Sherwood Medical Co. (Mchenry, US). The FDA issued a Cleared decision on August 8, 1983 after a review of 46 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - the FDA general hospital 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 Sherwood Medical Co. devices

Submission Details

510(k) Number	K832027 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	June 23, 1983
Decision Date	August 08, 1983
Days to Decision	46 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	-
Third-party Review	No - reviewed directly by FDA
Combination Product	No
PCCP Authorized	No

Regulatory Context

Review time vs. panel average

83d faster than avg

Panel avg: 129d · This submission: 46d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	JOL Catheter And Tip, Suction
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 880.6740

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General Hospital devices follow this clearance model.

Regulatory Peers - JOL Catheter And Tip, Suction

All 24

Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K832027.

DEKNATEL TROCAR CATHETER

K873525 · Deknatel, Inc. · Nov 1987

ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT

K870572 · Arrow Intl., Inc. · May 1987

'EXMOOR' ZOELLNER SUCKER ENDS

K864937 · Exmoor Plastics , Ltd. · Mar 1987

METAL BACKED ACETABULAR COMPONENT

K821342 · Intermedics Orthopedics · May 1982

ARGYLE THORACIC CATHETERS

K820718 · Sherwood Medical Co. · Apr 1982

ARGYLE UNIVERSAL POOLE SUCTION TUBE

K803187 · Sherwood Medical Co. · Jan 1981

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 K832027

Sherwood Medical Co.

Mchenry, IL · US

Regulatory profile

191 submissions 177 cleared

93% clearance rate · Active in General Hospital

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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