Cleared Traditional

K811185 - N-D0-SURE

K811185 is an FDA 510(k) clearance for N-D0-SURE, manufactured by Ackrad Laboratories. The device is a Class 1 Anesthesiology device with product code CBH cleared through the Traditional 510(k) pathway after a 34-day FDA review.

K811185 · Ackrad Laboratories · Anesthesiology device
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Jun 1981
Decision
34d
Days
Class 1
Risk

K811185 is an FDA 510(k) clearance for the N-D0-SURE. Classified as Device, Fixation, Tracheal Tube (product code CBH), Class I - General Controls.

Submitted by Ackrad Laboratories (Mchenry, US). The FDA issued a Cleared decision on June 2, 1981 after a review of 34 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5770 - 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 Ackrad Laboratories devices

FDA 510(k) Submission Details - K811185

510(k) Number K811185 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1981
Decision Date June 02, 1981
Days to Decision 34 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
106d faster than avg
Panel avg: 140d · This submission: 34d
Pathway characteristics
Predicate-based equivalence.

CBH Device Classification - Class 1, General Controls

Product Code CBH Device, Fixation, Tracheal Tube
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5770
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 - CBH Device, Fixation, Tracheal Tube

All 10
Devices cleared under the same product code (CBH) and FDA review panel - the closest regulatory comparables to K811185.
RESPIRONICS SECUREASY
K860845 · Respironics, Inc. · Mar 1986
OR TUBE RESTRAINT
K851874 · Kinetic Concepts, Inc. · Aug 1985
RESPIRONICS ENDO TUBE CONTROL SYS
K822794 · Respironics, Inc. · Oct 1982
ENDOTRACHEAL TUBE HOLDER
K802601 · Hudson Oxygen Therapy Sales Co. · Dec 1980
LUBE-LOK
K781695 · Olympic Medical Corp. · Nov 1978