Cleared Traditional

K801614 - MODEL 40-30-2 AIR ELIMINATING FILTER SET

K801614 is an FDA 510(k) clearance for MODEL 40-30-2 AIR ELIMINATING FILTER SET, manufactured by Y. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K801614 · Y · General Hospital
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Aug 1980
Decision
29d
Days
Class 2
Risk

K801614 is an FDA 510(k) clearance for the MODEL 40-30-2 AIR ELIMINATING FILTER SET. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Y (Mchenry, US). The FDA issued a Cleared decision on August 13, 1980 after a review of 29 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 Y devices

FDA 510(k) Submission Details - K801614

510(k) Number K801614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 15, 1980
Decision Date August 13, 1980
Days to Decision 29 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
100d faster than avg
Panel avg: 129d · This submission: 29d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPB Device Classification - Class 2, Special Controls

Product Code FPB Filter, Infusion Line
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 - FPB Filter, Infusion Line

All 72
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K801614.
BACTAGARD
K811773 · Tri-Med, Inc. · Jul 1981
TERFUSION FINAL FILTER SET
K810113 · Terumo Medical Corp. · Mar 1981
ACRODISC FILTER ASSEMBLY
K802765 · Gelman Sciences, Inc. · Jan 1981
BIMECO FILTERED EXTENSION SET
K801605 · Burron Medical Products, Inc. · Aug 1980
B-D FILTER NEEDLE
K801343 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Jun 1980
MICROBAR MONITORING LINE FILTER
K792510 · Medex, Inc. · Dec 1979