Cleared Traditional

K833076 - C-FLEX MEDICAL GRADE TUBING

K833076 is an FDA 510(k) clearance for C-FLEX MEDICAL GRADE TUBING, manufactured by Concept, Inc.. The device is a Class 2 General Hospital device with product code FPK cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K833076 · Concept, Inc. · General Hospital
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Nov 1983
Decision
73d
Days
Class 2
Risk

K833076 is an FDA 510(k) clearance for the C-FLEX MEDICAL GRADE TUBING. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Concept, Inc. (Mchenry, US). The FDA issued a Cleared decision on November 21, 1983 after a review of 73 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.5440 - 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 Concept, Inc. devices

FDA 510(k) Submission Details - K833076

510(k) Number K833076 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 1983
Decision Date November 21, 1983
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPK Device Classification - Class 2, Special Controls

Product Code FPK Tubing, Fluid Delivery
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5440
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 - FPK Tubing, Fluid Delivery

All 20
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K833076.
EXTENSION TUBE PUMP SET
K871085 · Churchill Corp. · Jun 1987
CHURCHILL EXTENSION TUBE
K861626 · Churchill Corp. · Jun 1986
CHURCHILL-H EXTENSION TUBE
K854629 · Churchill Corp. · Dec 1985
SAFEED EXTENSION TUBES
K810005 · Terumo Medical Corp. · Feb 1981
EXTENSION SET QUEST CODE #3000
K800825 · Quest Medical, Inc. · May 1980
MONITORING LINES & FLUID ADMIN.
K771387 · Norton Performance Plastics Corp. · Aug 1977