Cleared Traditional

K800635 - C.C.-PAK

K800635 is an FDA 510(k) clearance for C.C.-PAK, manufactured by Respiratory Care, Inc.. The device is a Class 2 General Hospital device with 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

FDA 510(k) Submission Details - K800635

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
Combination Product No
PCCP Authorized No
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.

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 46
Devices cleared under the same product code (JOL) and FDA review panel - the closest regulatory comparables to K800635.
ARGYLE UNIVERSAL POOLE SUCTION TUBE
K803187 · Sherwood Medical Co. · Jan 1981
MACROVAC
K801127 · Progress Mankind Technology · May 1980
MICROVAC
K801134 · Progress Mankind Technology · May 1980
ABCO SUCTION CATHETER & KITS W/GLOVE&CUP
K800234 · Abco Dealers, Inc. · Feb 1980
CONPHAR FINGERTIP SUCTION CONTROL
K791801 · Conphar, Inc. · Sep 1979
HYSTERECTOMY T DRAIN
K782027 · Davol, Inc. · Dec 1978