Cleared Traditional

K840669 - SUCTION DEVICE-PHARYNEAL DEVICE

K840669 is an FDA 510(k) clearance for SUCTION DEVICE-PHARYNEAL DEVICE, manufactured by Lipsky-Dale Medical Products. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 132-day FDA review.

K840669 · Lipsky-Dale Medical Products · General Hospital
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Jun 1984
Decision
132d
Days
Class 2
Risk

K840669 is an FDA 510(k) clearance for the SUCTION DEVICE-PHARYNEAL DEVICE. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Lipsky-Dale Medical Products (Walker, US). The FDA issued a Cleared decision on June 11, 1984 after a review of 132 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Lipsky-Dale Medical Products devices

FDA 510(k) Submission Details - K840669

510(k) Number K840669 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 31, 1984
Decision Date June 11, 1984
Days to Decision 132 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
3d slower than avg
Panel avg: 129d · This submission: 132d
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 53
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K840669.
IMPACT TURBO CATH
K851611 · Impact Instrumentation, Inc. · Jun 1985
THORA-CATH TROCAR-TYPE CHEST DRAINAGE TUBE
K851385 · Gesco Intl., Inc. · May 1985
PHARMA-PLAST SUCTION TIP, TYPE ORTHOPAE-
K843469 · Zimmar Consulting , Ltd. · Nov 1984
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