Cleared Traditional

K862435 - DOUBLE LUMEN E T ADAPTOR

K862435 is an FDA 510(k) clearance for DOUBLE LUMEN E T ADAPTOR, manufactured by Acutronic Medical Systems AG. The device is a Class 1 Anesthesiology device with product code BZA cleared through the Traditional 510(k) pathway after a 118-day FDA review.

K862435 · Acutronic Medical Systems AG · Anesthesiology device
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Oct 1986
Decision
118d
Days
Class 1
Risk

K862435 is an FDA 510(k) clearance for the DOUBLE LUMEN E T ADAPTOR. Classified as Connector, Airway (extension) (product code BZA), Class I - General Controls.

Submitted by Acutronic Medical Systems AG (Jona-Rapper Swril, CH). The FDA issued a Cleared decision on October 22, 1986 after a review of 118 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5810 - 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Acutronic Medical Systems AG devices

FDA 510(k) Submission Details - K862435

510(k) Number K862435 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 26, 1986
Decision Date October 22, 1986
Days to Decision 118 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
22d faster than avg
Panel avg: 140d · This submission: 118d
Pathway characteristics
Predicate-based equivalence.

BZA Device Classification - Class 1, General Controls

Product Code BZA Connector, Airway (extension)
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 868.5810
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 - BZA Connector, Airway (extension)

All 58
Devices cleared under the same product code (BZA) and FDA review panel - the closest regulatory comparables to K862435.
MEDICOMP STRAIGHT SWIVEL ADAPTOR
K880434 · Medicomp, Inc. · Mar 1988
MEDICOMP INHALANT MASK ELBOW
K864896 · Medicomp, Inc. · Feb 1987
SALTER LABS MODEL #4005 GAS SAMPLING TEE AND LINE
K865046 · Salter Labs · Jan 1987
INSPIRON DOUBLE SWIVEL TRACH ADAPTER
K860838 · Inspiron Corp. · Apr 1986
BRITISH BREATHING CIRCUIT SYSTEM
K860878 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986
DISPOSABLE CATHETER
K860882 · Dhd Medical Products Div. Diemolding Corp. · Mar 1986