Cleared Traditional

K800825 - EXTENSION SET QUEST CODE #3000

K800825 is the FDA 510(k) clearance for EXTENSION SET QUEST CODE #3000 by Quest Medical, Inc.. It is a Class 2 General Hospital device (product code FPK) cleared through the Traditional 510(k) pathway after a 30-day FDA review.

K800825 · Quest Medical, Inc. · General Hospital
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May 1980
Decision
30d
Days
Class 2
Risk

K800825 is an FDA 510(k) clearance for the EXTENSION SET QUEST CODE #3000. Classified as Tubing, Fluid Delivery (product code FPK), Class II - Special Controls.

Submitted by Quest Medical, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 14, 1980 after a review of 30 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 Quest Medical, Inc. devices

Submission Details

510(k) Number K800825 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 14, 1980
Decision Date May 14, 1980
Days to Decision 30 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
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 K800825.
CHURCHILL-H EXTENSION TUBE
K854629 · Churchill Corp. · Dec 1985
C-FLEX MEDICAL GRADE TUBING
K833076 · Concept, Inc. · Nov 1983
SAFEED EXTENSION TUBES
K810005 · Terumo Medical Corp. · Feb 1981
MONITORING LINES & FLUID ADMIN.
K771387 · Norton Performance Plastics Corp. · Aug 1977
CONNECTORS
K770596 · Abco Dealers, Inc. · Jun 1977