Cleared Traditional

K800825 - EXTENSION SET QUEST CODE #3000

K800825 is an FDA 510(k) clearance for EXTENSION SET QUEST CODE #3000, manufactured by Quest Medical, Inc.. The device is a Class 2 General Hospital device with 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.

FDA 510(k) Submission Details - K800825

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.

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 61
Devices cleared under the same product code (FPK) and FDA review panel - the closest regulatory comparables to K800825.
FLUVEN SETS (EXT-1, EXT-2, EXT-3, EXT-4)
K812981 · Venusa , Ltd. · Nov 1981
SEA MEDICAL PRODUCTS LO-VOL
K811847 · Sea Medical Products, Inc. · Jul 1981
SAFEED EXTENSION TUBES
K810005 · Terumo Medical Corp. · Feb 1981
MEDICAL GRADE SILICONE ELASTOMER TUBING
K781087 · Mcghan Medical Corp. · Nov 1978
CENTRAL CATHETER KIT
K780673 · Argon Medical Corp. · May 1978
NASAL GASTRIC TUBE RETAINER
K780396 · Mor-Mac, Inc. · Mar 1978
K800825 · EXTENSION SET QUEST CODE #3000
Download PDF Quest Medical, Inc.