Cleared Traditional

K892441 - KENDALL CURITY SUCTION CATHETERS

K892441 is an FDA 510(k) clearance for KENDALL CURITY SUCTION CATHETERS, manufactured by The Kendal Co.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 51-day FDA review.

K892441 · The Kendal Co. · Anesthesiology device
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May 1989
Decision
51d
Days
Class 1
Risk

K892441 is an FDA 510(k) clearance for the KENDALL CURITY SUCTION CATHETERS. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by The Kendal Co. (Boston, US). The FDA issued a Cleared decision on May 31, 1989 after a review of 51 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 The Kendal Co. devices

FDA 510(k) Submission Details - K892441

510(k) Number K892441 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 10, 1989
Decision Date May 31, 1989
Days to Decision 51 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
89d faster than avg
Panel avg: 140d · This submission: 51d
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 K892441.
TRACHAEL SUCTION SET
K896887 · Orion Life Systems, Inc. · Apr 1990
SUCTION CATHETER KIT
K896797 · Westmark, Sterile Packing Systems, Inc. (Sps) · Feb 1990
MUCOUS TRAP
K896560 · Westmark, Sterile Packing Systems, Inc. (Sps) · Jan 1990
RESPIRONICS SUCTIONEASY
K882017 · Respironics, Inc. · Jul 1988
STERILE MUCUS SPECIMEN TRAP, MODELS 406 & 407
K875058 · Busse Hospital Disposables, Inc. · Feb 1988
SAFETY SHIELD SUCTION CATHETER
K873810 · Ballard Medical Products · Dec 1987