Cleared Traditional

K842198 - AMER. PHARMASEAL NO TOUCH SATIN CATHET

K842198 is an FDA 510(k) clearance for AMER. PHARMASEAL NO TOUCH SATIN CATHET, manufactured by American Pharmaseal Div. Ahsc. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 21-day FDA review.

K842198 · American Pharmaseal Div. Ahsc · Anesthesiology device
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Jun 1984
Decision
21d
Days
Class 1
Risk

K842198 is an FDA 510(k) clearance for the AMER. PHARMASEAL NO TOUCH SATIN CATHET. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by American Pharmaseal Div. Ahsc (Mchenry, US). The FDA issued a Cleared decision on June 25, 1984 after a review of 21 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.

View all American Pharmaseal Div. Ahsc devices

FDA 510(k) Submission Details - K842198

510(k) Number K842198 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 04, 1984
Decision Date June 25, 1984
Days to Decision 21 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
119d faster than avg
Panel avg: 140d · This submission: 21d
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 53
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K842198.
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
OXY-VAC
K842205 · Medi-Tech, Inc. · Jun 1984
TRACHEOSTOMY CLEANING TRAY
K840664 · American Pharmaseal Div. Ahsc · Mar 1984
BRONCHITRAC DF DUAL RESP/CATHETER
K833633 · Ackrad Laboratories · Dec 1983