Cleared Traditional

K811241 - BODAI SUCTION -SAFE 4

K811241 is the FDA 510(k) clearance for BODAI SUCTION -SAFE 4 by Sontek Industries, Inc.. It is a Class 1 Anesthesiology device (product code BSY) cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K811241 · Sontek Industries, Inc. · Anesthesiology device
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May 1981
Decision
23d
Days
Class 1
Risk

K811241 is an FDA 510(k) clearance for the BODAI SUCTION -SAFE 4. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Sontek Industries, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 27, 1981 after a review of 23 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 Sontek Industries, Inc. devices

Submission Details

510(k) Number K811241 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1981
Decision Date May 27, 1981
Days to Decision 23 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
117d faster than avg
Panel avg: 140d · This submission: 23d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 15
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K811241.
ARGYLE SUCTION CATHETERS
K830709 · Sherwood Medical Co. · Mar 1983
RADIATION STERILIZED SUCTION CATHETERS
K820109 · Travenol Laboratories, S.A. · Jan 1982
ARGYLE SUCTION CATHETERS
K812747 · Sherwood Medical Co. · Oct 1981
HYDROPHILIC COATED CATHETER
K810023 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1981
ARGYLE SAF-T-MARK SUCTION CATHETER
K801551 · Sherwood Medical Co. · Jul 1980
CONPHAR SUCTION CATHETER-W/0 CONTROL
K791253 · Conphar, Inc. · Jul 1979