Cleared Traditional

K860535 - UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS)

K860535 is an FDA 510(k) clearance for UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS), manufactured by Andover Medical, Inc.. The device is a Class 1 Anesthesiology device with product code CAT cleared through the Traditional 510(k) pathway after a 48-day FDA review.

K860535 · Andover Medical, Inc. · Anesthesiology device
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Apr 1986
Decision
48d
Days
Class 1
Risk

K860535 is an FDA 510(k) clearance for the UNILATERAL OXYGEN DELIVERY SYSTEM (ULODS). Classified as Cannula, Nasal, Oxygen (product code CAT), Class I - General Controls.

Submitted by Andover Medical, Inc. (Lawrence, US). The FDA issued a Cleared decision on April 1, 1986 after a review of 48 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5340 - 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 Andover Medical, Inc. devices

FDA 510(k) Submission Details - K860535

510(k) Number K860535 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 12, 1986
Decision Date April 01, 1986
Days to Decision 48 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
92d faster than avg
Panel avg: 140d · This submission: 48d
Pathway characteristics
Predicate-based equivalence.

CAT Device Classification - Class 1, General Controls

Product Code CAT Cannula, Nasal, Oxygen
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5340
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 - CAT Cannula, Nasal, Oxygen

All 19
Devices cleared under the same product code (CAT) and FDA review panel - the closest regulatory comparables to K860535.
KENDALL CURITY OXYGEN NASAL CANNULA
K892435 · The Kendal Co. · Jun 1989
OXYGEN CANNULA EAR WRAP (STYLE A)
K863431 · Salter Labs · Sep 1986
OXYGEN CANNULA EAR WRAP (STYLE B)
K863432 · Salter Labs · Sep 1986
NASAL CANNULA W/2M & 5M TUBING
K860872 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
PHARMA-PLAST NASAL OXYGEN CANNULA
K843467 · Zimmar Consulting , Ltd. · Nov 1984
CHAD ADJUSTABLE CANNULA
K842968 · Chad Therapeutics, Inc. · Aug 1984