Cleared Traditional

K840849 - SCAVENGER TUBING 19MM

K840849 is an FDA 510(k) clearance for SCAVENGER TUBING 19MM, manufactured by The Kendal Co.. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 17-day FDA review.

K840849 · The Kendal Co. · Anesthesiology device
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Mar 1984
Decision
17d
Days
Class 2
Risk

K840849 is an FDA 510(k) clearance for the SCAVENGER TUBING 19MM. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by The Kendal Co. (Mchenry, US). The FDA issued a Cleared decision on March 12, 1984 after a review of 17 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.5430 - 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 The Kendal Co. devices

FDA 510(k) Submission Details - K840849

510(k) Number K840849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 24, 1984
Decision Date March 12, 1984
Days to Decision 17 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
123d faster than avg
Panel avg: 140d · This submission: 17d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBN Device Classification - Class 2, Special Controls

Product Code CBN Apparatus, Gas-scavenging
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.5430
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 - CBN Apparatus, Gas-scavenging

All 13
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K840849.
GAS EVACUATION ACCESSORY
K852772 · Siemens Elema AB · Oct 1985
OHIO WASTE GAS SCAVENGING RESERVOIR
K841733 · Ohio Medical Products · Jul 1984
OHIO WASTE GAS SCAVENGING INTERFACE
K842003 · Ohio Medical Products · May 1984
POSIVAC
K791127 · Vital Signs, Inc. · Jul 1979
NAD SCAVENGING RELIEF VALVE
K790333 · Draeger Medical, Inc. · Mar 1979
SH-1
K770344 · Delta Medical Industries · May 1977