Cleared Traditional

K981910 - SUCTION CATHETER

K981910 is an FDA 510(k) clearance for SUCTION CATHETER, manufactured by Ni-Med, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 84-day FDA review.

K981910 · Ni-Med, Inc. · Anesthesiology device
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Aug 1998
Decision
84d
Days
Class 1
Risk

K981910 is an FDA 510(k) clearance for the SUCTION CATHETER. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Ni-Med, Inc. (Farmington, US). The FDA issued a Cleared decision on August 24, 1998 after a review of 84 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 Ni-Med, Inc. devices

FDA 510(k) Submission Details - K981910

510(k) Number K981910 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 01, 1998
Decision Date August 24, 1998
Days to Decision 84 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
56d faster than avg
Panel avg: 140d · This submission: 84d
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 69
Devices cleared under the same product code (BSY) and FDA review panel - the closest regulatory comparables to K981910.
AMBU HAND POWER SUCTION PUMP
K992902 · Ambu, Inc. · Oct 1999
DUAL PURPOSE CLOSED CATHETER
K982945 · Spirit Medical Systems, Inc. · Sep 1998
HI-CARE CLOSED SUCTION SYSTEM
K972258 · Mallinckrodt Medical · Dec 1997
AMSINO SUCTION CATHETER
K973199 · Amsino Intl., Inc. · Sep 1997
TRACH-EZE CLOSED VENTILATION SUCTION SYSTEM
K961707 · Sorenson Critical Care · Mar 1997
TRACH CARE SET WITH MICROBAN
K964369 · Ballard Medical Products · Feb 1997