Cleared Traditional

K770183 - O.22/UM FILTERSET W/FLASHBACK

K770183 is an FDA 510(k) clearance for O.22/UM FILTERSET W/FLASHBACK, manufactured by Abbott Laboratories. The device is a Class 2 General Hospital device with product code FPB cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K770183 · Abbott Laboratories · General Hospital
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Feb 1977
Decision
13d
Days
Class 2
Risk

K770183 is an FDA 510(k) clearance for the O.22/UM FILTERSET W/FLASHBACK. Classified as Filter, Infusion Line (product code FPB), Class II - Special Controls.

Submitted by Abbott Laboratories (Abbott Park, US). The FDA issued a Cleared decision on February 9, 1977 after a review of 13 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.

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FDA 510(k) Submission Details - K770183

510(k) Number K770183 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 27, 1977
Decision Date February 09, 1977
Days to Decision 13 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
116d faster than avg
Panel avg: 129d · This submission: 13d
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.