Cleared Traditional

K800635 - C.C.-PAK

K800635 is the FDA 510(k) clearance for C.C.-PAK by Respiratory Care, Inc.. It is a Class 2 General Hospital device (product code JOL) cleared through the Traditional 510(k) pathway after a 20-day FDA review.

K800635 · Respiratory Care, Inc. · General Hospital
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Apr 1980
Decision
20d
Days
Class 2
Risk

K800635 is an FDA 510(k) clearance for the C.C.-PAK. Classified as Catheter And Tip, Suction (product code JOL), Class II - Special Controls.

Submitted by Respiratory Care, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 10, 1980 after a review of 20 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 Respiratory Care, Inc. devices

Submission Details

510(k) Number K800635 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 21, 1980
Decision Date April 10, 1980
Days to Decision 20 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
109d faster than avg
Panel avg: 129d · This submission: 20d
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 16
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K800635.
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
ABCO SUCTION CATHETER & KITS W/GLOVE&CUP
K800234 · Abco Dealers, Inc. · Feb 1980
CONPHAR FINGERTIP SUCTION CONTROL
K791801 · Conphar, Inc. · Sep 1979
SUCTION KIT
K760586 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Nov 1976