Cleared Traditional

K840943 - ENDO-JECT

K840943 is the FDA 510(k) clearance for ENDO-JECT by Autovage. It is a Class 2 Anesthesiology device (product code BTR) cleared through the Traditional 510(k) pathway after a 81-day FDA review.

K840943 · Autovage · Anesthesiology device

Download Printable Device Report (PDF)

Optimized for regulatory review, auditing and printing

May 1984

Decision

81d

Days

Class 2

Risk

K840943 is an FDA 510(k) clearance for the ENDO-JECT. Classified as Tube, Tracheal (w/wo Connector) (product code BTR), Class II - Special Controls.

Submitted by Autovage (Walker, US). The FDA issued a Cleared decision on May 25, 1984 after a review of 81 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5730 - 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 Autovage devices

Submission Details

510(k) Number	K840943 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	March 05, 1984
Decision Date	May 25, 1984
Days to Decision	81 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	-
Third-party Review	No - reviewed directly by FDA

Regulatory Context

Review time vs. panel average

59d faster than avg

Panel avg: 140d · This submission: 81d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	BTR Tube, Tracheal (w/wo Connector)
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 868.5730

What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Anesthesiology devices follow this clearance model.

Regulatory Peers - BTR Tube, Tracheal (w/wo Connector)

All 63

Devices cleared under the same product code (BTR) and FDA review panel - the closest regulatory comparables to K840943.

DOUBLE CONTOURED CUFF TRACHEAL TUBE

K843714 · Ohmeda Medical · Oct 1984

UNCUFFED REINFORCED TRACHEAL TUBE

K841872 · Mallinckrodt Critical Care · Jul 1984

TRACHEAL TUBE/STETHOSCOPE

K842464 · Mallinckrodt Critical Care · Jul 1984

3-DAY BIOINDICATOR RELEASE FOR STERIL

K833831 · Shiley, Inc. · Mar 1984

ARGYLE JET TRACHEAL TUBE

K833807 · Sherwood Medical Co. · Jan 1984

TRACH SWIVE/CONNECTOR

K833197 · Airlife, Inc. · Oct 1983

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.

Manufacturer of K840943

Autovage

Walker, MI · US

Regulatory profile

7 submissions 6 cleared

86% clearance rate · Active in Anesthesiology

Data Intelligence Layer

This record restructures FDA 510(k) public data into device-level regulatory intelligence - enabling comparison across product codes, clearance pathways, review times and manufacturer patterns.

Classification enrichment, manufacturer tracking and cross-device links are added to support regulatory research and predicate analysis workflows.

Sourced from FDA 510(k) public files . Updated monthly.

Verify on FDA.gov

510k Database

510(k) clearances indexed 175,450

Regulatory data since 1976

FDA monthly sync Active