Cleared Traditional

K791801 - CONPHAR FINGERTIP SUCTION CONTROL

K791801 is an FDA 510(k) clearance for CONPHAR FINGERTIP SUCTION CONTROL, manufactured by Conphar, Inc.. The device is a Class 2 General Hospital device with product code JOL cleared through the Traditional 510(k) pathway after a 8-day FDA review.

K791801 · Conphar, Inc. · General Hospital
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Sep 1979
Decision
8d
Days
Class 2
Risk

K791801 is an FDA 510(k) clearance for the CONPHAR FINGERTIP SUCTION CONTROL. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Conphar, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 21, 1979 after a review of 8 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 Conphar, Inc. devices

FDA 510(k) Submission Details - K791801

510(k) Number K791801 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 13, 1979
Decision Date September 21, 1979
Days to Decision 8 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
121d faster than avg
Panel avg: 129d · This submission: 8d
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 39
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K791801.
ARGYLE UNIVERSAL POOLE SUCTION TUBE
K803187 · Sherwood Medical Co. · Jan 1981
C.C.-PAK
K800635 · Respiratory Care, Inc. · Apr 1980
ABCO SUCTION CATHETER & KITS W/GLOVE&CUP
K800234 · Abco Dealers, Inc. · Feb 1980
HYSTERECTOMY T DRAIN
K782027 · Davol, Inc. · Dec 1978
CATHETER THORACIC, AXIOM
K770983 · Axiom Medical, Inc. · Jul 1977
SUCTION KIT
K760586 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1976