Cleared Traditional

K896797 - SUCTION CATHETER KIT

K896797 is an FDA 510(k) clearance for SUCTION CATHETER KIT, manufactured by Westmark, Sterile Packing Systems, Inc. (Sps). The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 77-day FDA review.

K896797 · Westmark, Sterile Packing Systems, Inc. (Sps) · Anesthesiology device
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Feb 1990
Decision
77d
Days
Class 1
Risk

K896797 is an FDA 510(k) clearance for the SUCTION CATHETER KIT. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Westmark, Sterile Packing Systems, Inc. (Sps) (Grand Rapids, US). The FDA issued a Cleared decision on February 16, 1990 after a review of 77 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 Westmark, Sterile Packing Systems, Inc. (Sps) devices

FDA 510(k) Submission Details - K896797

510(k) Number K896797 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 01, 1989
Decision Date February 16, 1990
Days to Decision 77 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
63d faster than avg
Panel avg: 140d · This submission: 77d
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 63
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K896797.
SUCTION CATHETER, STERILE
K902814 · Orion Life Systems, Inc. · Aug 1990
STERI-CATH(TM)
K902383 · Concord/Portex · Jul 1990
TRACHAEL SUCTION SET
K896887 · Orion Life Systems, Inc. · Apr 1990
MUCOUS TRAP
K896560 · Westmark, Sterile Packing Systems, Inc. (Sps) · Jan 1990
KENDALL CURITY SUCTION CATHETERS
K892441 · The Kendal Co. · May 1989
SUCTION CONTROL VALVE
K892343 · Concord/Portex · Apr 1989