Cleared Traditional

K842003 - OHIO WASTE GAS SCAVENGING INTERFACE

K842003 is an FDA 510(k) clearance for OHIO WASTE GAS SCAVENGING INTERFACE, manufactured by Ohio Medical Products. The device is a Class 2 Anesthesiology device with product code CBN cleared through the Traditional 510(k) pathway after a 7-day FDA review.

K842003 · Ohio Medical Products · Anesthesiology device
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May 1984
Decision
7d
Days
Class 2
Risk

K842003 is an FDA 510(k) clearance for the OHIO WASTE GAS SCAVENGING INTERFACE. Classified as Apparatus, Gas-scavenging (product code CBN), Class II - Special Controls.

Submitted by Ohio Medical Products (Mchenry, US). The FDA issued a Cleared decision on May 23, 1984 after a review of 7 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 Ohio Medical Products devices

FDA 510(k) Submission Details - K842003

510(k) Number K842003 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 16, 1984
Decision Date May 23, 1984
Days to Decision 7 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
133d faster than avg
Panel avg: 140d · This submission: 7d
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 14
Devices cleared under the same product code (CBN) and FDA review panel - the closest regulatory comparables to K842003.
OPEN RESERVOIR SCAVENGER
K864034 · Draeger Medical, Inc. · Dec 1986
GAS EVACUATION ACCESSORY
K852772 · Siemens Elema AB · Oct 1985
OHIO WASTE GAS SCAVENGING RESERVOIR
K841733 · Ohio Medical Products · Jul 1984
SCAVENGER TUBING 19MM
K840849 · The Kendal Co. · Mar 1984
POSIVAC
K791127 · Vital Signs, Inc. · Jul 1979
NAD SCAVENGING RELIEF VALVE
K790333 · Draeger Medical, Inc. · Mar 1979