Cleared Traditional

K811241 - BODAI SUCTION -SAFE 4

K811241 is an FDA 510(k) clearance for BODAI SUCTION -SAFE 4, manufactured by Sontek Industries, Inc.. The device is a Class 1 Anesthesiology device with 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

FDA 510(k) Submission Details - K811241

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.

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 70
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K811241.
SUCTION CATHETERS & KITS
K820369 · American Pharmaseal Div. Ahsc · Apr 1982
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
CATHETER SUCTION TRACHEOBRONCHIAL
K801814 · Concord Laboratories, Inc. · Aug 1980
ARGYLE SAF-T-MARK SUCTION CATHETER
K801551 · Sherwood Medical Co. · Jul 1980