Cleared Traditional

K842779 - ACT, SUCTION TIP

K842779 is an FDA 510(k) clearance for ACT, manufactured by Edward Manougian, M.D.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 88-day FDA review.

K842779 · Edward Manougian, M.D. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 1984
Decision
88d
Days
Class 1
Risk

K842779 is an FDA 510(k) clearance for the ACT, SUCTION TIP. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Edward Manougian, M.D. (Berkeley, US). The FDA issued a Cleared decision on October 12, 1984 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.6810 - the FDA anesthesiology and respiratory 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.

FDA 510(k) Submission Details - K842779

510(k) Number K842779 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 16, 1984
Decision Date October 12, 1984
Days to Decision 88 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 140d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

BSY Device Classification - Class 1, General Controls

Product Code BSY Catheters, Suction, Tracheobronchial
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.6810
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - BSY Catheters, Suction, Tracheobronchial

All 84
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K842779.
VYGON DELEE SUCTION CATHETER CODE NO 533
K851473 · Vygon Corp. · Jul 1985
BRONCHITRAC L
K850784 · Ackrad Laboratories · Mar 1985
SUCTION CATHETER KIT
K843076 · Travenol Laboratories, S.A. · Nov 1984
JINOTTI OXYGEN/SUCTION CATHETER
K841425 · Research Medical, Inc. · Sep 1984
AMER. PHARMASEAL NO TOUCH SATIN CATHET
K842198 · American Pharmaseal Div. Ahsc · Jun 1984
OXY-VAC
K842205 · Medi-Tech, Inc. · Jun 1984
K842779 · ACT, SUCTION TIP
Download PDF Edward Manougian, M.D.