Cleared Traditional

K790035 - AMBU SUCTION BOOSTER

K790035 is an FDA 510(k) clearance for AMBU SUCTION BOOSTER, manufactured by Narco Air-Shields. The device is a Class 2 General Hospital device with product code CBC cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K790035 · Narco Air-Shields · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 1979
Decision
77d
Days
Class 2
Risk

K790035 is an FDA 510(k) clearance for the AMBU SUCTION BOOSTER. Classified as Bottle, Collection And Trap, Breathing System (uncalibrated) (product code CBC), Class II - Special Controls.

Submitted by Narco Air-Shields (Mchenry, US). The FDA issued a Cleared decision on March 23, 1979 after a review of 77 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 880.6740 - 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 Narco Air-Shields devices

FDA 510(k) Submission Details - K790035

510(k) Number K790035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 05, 1979
Decision Date March 23, 1979
Days to Decision 77 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
52d faster than avg
Panel avg: 129d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBC Device Classification - Class 2, Special Controls

Product Code CBC Bottle, Collection And Trap, Breathing System (uncalibrated)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.6740
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.