Cleared Traditional

K871950 - VIA-GUARD

K871950 is the FDA 510(k) clearance for VIA-GUARD by Surgimark, Inc.. It is a Class 2 General Hospital device (product code JOL) cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K871950 · Surgimark, Inc. · General Hospital

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Jul 1987

Decision

64d

Days

Class 2

Risk

K871950 is an FDA 510(k) clearance for the VIA-GUARD. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Surgimark, Inc. (Yakima, US). The FDA issued a Cleared decision on July 23, 1987 after a review of 64 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 Surgimark, Inc. devices

Submission Details

510(k) Number	K871950 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	May 20, 1987
Decision Date	July 23, 1987
Days to Decision	64 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

65d faster than avg

Panel avg: 129d · This submission: 64d

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 33

Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K871950.

URESIL THORA-FLO THORACENTESIS PROCEDURE KIT

K872948 · Uresil Corp. · Nov 1987

DEKNATEL THORACIC CATHETER

K873517 · Deknatel, Inc. · Nov 1987

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

ARGYLE YANKAVER SUCTION TUBE W/CONTROL

K832027 · Sherwood Medical Co. · Aug 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 K871950

Surgimark, Inc.

Yakima, WA · US

RICHARD J YARGER,MD

Regulatory profile

3 submissions 3 cleared

100% 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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