Cleared Traditional

K873081 - EDENTEC MULTI-CHANNEL RECORDER

K873081 is an FDA 510(k) clearance for EDENTEC MULTI-CHANNEL RECORDER, manufactured by Edentec Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 104-day FDA review.

K873081 · Edentec Corp. · Anesthesiology device
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Nov 1987
Decision
104d
Days
Class 2
Risk

K873081 is an FDA 510(k) clearance for the EDENTEC MULTI-CHANNEL RECORDER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on November 17, 1987 after a review of 104 days - within the typical 510(k) review window.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 870.2700 - 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 Edentec Corp. devices

FDA 510(k) Submission Details - K873081

510(k) Number K873081 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 1987
Decision Date November 17, 1987
Days to Decision 104 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
36d faster than avg
Panel avg: 140d · This submission: 104d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DQA Device Classification - Class 2, Special Controls

Product Code DQA Oximeter
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2700
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 - DQA Oximeter

All 502
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K873081.
OHMEDA 4700 OXICAP MONITOR
K873199 · Ohmeda Medical · Feb 1988
CARDIOCAP(TM) PULSE OXIMETRY MODULE COS-104
K873859 · Datex Division Instrumentarium Corp. · Dec 1987
OHMEDA BIOX 3760 PULSE OXIMETER
K874104 · Ohmeda Medical · Dec 1987
MODEL 7200A WITH PULSE OXIMETRY
K873065 · Puritan Bennett Corp. · Oct 1987
PULSE-OX
K863857 · Life Design Systems, Inc. · Oct 1987
OHMEDA BIOX 3740 PULSE OXIMETER
K872772 · Ohmeda Medical · Oct 1987