Cleared Traditional

K881428 - OXY-CATH

K881428 is an FDA 510(k) clearance for OXY-CATH, manufactured by Pulmonary Medical Devices, Inc.. The device is a Class 1 Anesthesiology device with product code BSY cleared through the Traditional 510(k) pathway after a 66-day FDA review.

K881428 · Pulmonary Medical Devices, Inc. · Anesthesiology device
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Jun 1988
Decision
66d
Days
Class 1
Risk

K881428 is an FDA 510(k) clearance for the OXY-CATH. Classified as Catheters, Suction, Tracheobronchial (product code BSY), Class I - General Controls.

Submitted by Pulmonary Medical Devices, Inc. (Berkley Heights, US). The FDA issued a Cleared decision on June 10, 1988 after a review of 66 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 Pulmonary Medical Devices, Inc. devices

FDA 510(k) Submission Details - K881428

510(k) Number K881428 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 05, 1988
Decision Date June 10, 1988
Days to Decision 66 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 140d · This submission: 66d
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 K881428.
KENDALL CURITY SUCTION CATHETERS
K892441 · The Kendal Co. · May 1989
SUCTION CONTROL VALVE
K892343 · Concord/Portex · Apr 1989
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
PEDIATRIC BUBBLE TRAP CAT. NO. B-100
K873610 · American Omni Medical, Inc. · Nov 1987