Cleared Traditional

K771536 - AIR VENT FILTER NEEDLE, 0.45

K771536 is an FDA 510(k) clearance for AIR VENT FILTER NEEDLE, manufactured by Jelco Laboratories. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 76-day FDA review.

K771536 · Jelco Laboratories · General Hospital
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Oct 1977
Decision
76d
Days
Class 2
Risk

K771536 is an FDA 510(k) clearance for the AIR VENT FILTER NEEDLE, 0.45. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Jelco Laboratories (Mchenry, US). The FDA issued a Cleared decision on October 25, 1977 after a review of 76 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 - K771536

510(k) Number K771536 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 10, 1977
Decision Date October 25, 1977
Days to Decision 76 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
53d faster than avg
Panel avg: 129d · This submission: 76d
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 69
Devices cleared under the same product code (FPB) and FDA review panel - the closest regulatory comparables to K771536.
FLUID ADMINISTRATION SETS, 15 MICRON
K790314 · Medex, Inc. · Mar 1979
FILTERSET W/Y-INJECTION SITE, 0.2
K772312 · Abbott Laboratories · Jan 1978
5UM FILTERSET WITH Y-INJECTION SITE
K771972 · Abbott Laboratories · Jan 1978
INTRAVENOUS FILTER W/AUTO AIR VENT
K771826 · Jelco Laboratories · Oct 1977
INTRAVENOUS FILTER W/FLASH BULB
K771827 · Jelco Laboratories · Oct 1977
TRANSFUSION BLOOD FILTER
K771862 · Medical, Inc. · Oct 1977