Cleared Traditional

K843188 - WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP

K843188 is an FDA 510(k) clearance for WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP, manufactured by Wells Johnson Co.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 38-day FDA review.

K843188 · Wells Johnson Co. · General Hospital
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Sep 1984
Decision
38d
Days
Class 2
Risk

K843188 is an FDA 510(k) clearance for the WELLS JOHNSON CO. CHAJ-CHIR-SUCTION TIP. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Wells Johnson Co. (Mchenry, US). The FDA issued a Cleared decision on September 20, 1984 after a review of 38 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 Wells Johnson Co. devices

FDA 510(k) Submission Details - K843188

510(k) Number K843188 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 13, 1984
Decision Date September 20, 1984
Days to Decision 38 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
91d faster than avg
Panel avg: 129d · This submission: 38d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

JOL Device Classification - Class 2, Special Controls

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 36
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K843188.
ARROW-CLARKE(TM) PLEURA-SEAL(TM) THORACENTESIS KIT
K870572 · Arrow Intl., Inc. · May 1987
'EXMOOR' ZOELLNER SUCKER ENDS
K864937 · Exmoor Plastics , Ltd. · Mar 1987
DEKNATEL THORACIC CATHETER
K852041 · Pfizer, Inc. · Jun 1985
ARGYLE YANKAVER SUCTION TUBE W/CONTROL
K832027 · Sherwood Medical Co. · Aug 1983
SUCTION CATHETERS
K830942 · Medovations, Inc. · Apr 1983
METAL BACKED ACETABULAR COMPONENT
K821342 · Intermedics Orthopedics · May 1982