Cleared Traditional

K770589 - FILTER, INTRAVENOUS W/AUTO AIR VENT

K770589 is an FDA 510(k) clearance for FILTER, manufactured by Jelco Laboratories. The device is a Class 2 General Hospital device with product code FPA cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K770589 · Jelco Laboratories · General Hospital
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May 1977
Decision
56d
Days
Class 2
Risk

K770589 is an FDA 510(k) clearance for the FILTER, INTRAVENOUS W/AUTO AIR VENT. Classified as Set, Administration, Intravascular (product code FPA), Class II - Special Controls.

Submitted by Jelco Laboratories (Mchenry, US). The FDA issued a Cleared decision on May 23, 1977 after a review of 56 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 Jelco Laboratories devices

FDA 510(k) Submission Details - K770589

510(k) Number K770589 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 28, 1977
Decision Date May 23, 1977
Days to Decision 56 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
73d faster than avg
Panel avg: 129d · This submission: 56d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FPA Device Classification - Class 2, Special Controls

Product Code FPA Set, Administration, Intravascular
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 - FPA Set, Administration, Intravascular

All 657
Devices cleared under the same product code (FPA) and FDA review panel - the closest regulatory comparables to K770589.
SOLUSET FOR IV FAT EMULSION
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BURETTE SET, 2C0132
K770763 · Travenol Laboratories, S.A. · Jun 1977
IV SET THAT REVERTS TO KVO RATE
K770744 · Abbott Laboratories · May 1977
PIGGYBACK VENOSET W/0.22 FILTER
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ERIKA I.V. ADMINISTRATION SET
K770171 · Erika, Inc. · Mar 1977
VENOSET FOR I.V. FAT EMULSION
K770051 · Abbott Laboratories · Feb 1977