Cleared Traditional

K884614 - EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.

K884614 is an FDA 510(k) clearance for EDENTEC MODEL 2000W OPTION S CARDIO-RES..., 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 89-day FDA review.

K884614 · Edentec Corp. · Anesthesiology device
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Feb 1989
Decision
89d
Days
Class 2
Risk

K884614 is an FDA 510(k) clearance for the EDENTEC MODEL 2000W OPTION S CARDIO-RESP. PROCESS.. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on February 1, 1989 after a review of 89 days - a notably fast clearance cycle.

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: 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 Edentec Corp. devices

FDA 510(k) Submission Details - K884614

510(k) Number K884614 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 1988
Decision Date February 01, 1989
Days to Decision 89 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
51d faster than avg
Panel avg: 140d · This submission: 89d
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 K884614.
CNS-8200A CENTRAL NURSES STATION
K884050 · Nihon Kohden America, Inc. · Feb 1989
AL-800PA PULSE OXIMETER MODULE
K884536 · Nihon Kohden America, Inc. · Feb 1989
MODEL 8700 PULSE OXIMETER
K890033 · Nonin Medical, Inc. · Feb 1989
SAT-2 OXIMETER/CARDIAC OUTPUT COMPUTER
K884329 · Baxter Healthcare Corp · Dec 1988
OLV 1100
K881307 · Nihon Kohden America, Inc. · Nov 1988
BM-103 BATTERY MODULE
K883877 · Datex Division Instrumentarium Corp. · Oct 1988