Cleared Traditional

K881820 - EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER

K881820 is an FDA 510(k) clearance for EDENTEC MODEL 2800/2801 OXIMETER/PULSE ..., 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 80-day FDA review.

K881820 · Edentec Corp. · Anesthesiology device
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Jul 1988
Decision
80d
Days
Class 2
Risk

K881820 is an FDA 510(k) clearance for the EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Edentec Corp. (Eden Prairie, US). The FDA issued a Cleared decision on July 18, 1988 after a review of 80 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 - K881820

510(k) Number K881820 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 29, 1988
Decision Date July 18, 1988
Days to Decision 80 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
60d faster than avg
Panel avg: 140d · This submission: 80d
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 K881820.
HEWLETT-PACKARD MODLES 78354A/78352 PULSE OXIMETER
K883297 · Hewlett-Packard Co. · Oct 1988
MRL OXIMETER
K882664 · Medical Research Laboratories, Inc. · Sep 1988
HORIZON 2000 PULSE OXIMETRY AND MODULE
K882273 · Mennen Medical, Inc. · Aug 1988
SATLITE+/PB251+ PULSE OXIMETER
K881883 · Datex Division Instrumentarium Corp. · Jul 1988
HEWLETT-PACKARD MODELS 78354A & 78352A PULSE OXI.
K881136 · Hewlett-Packard Co. · May 1988
502-US PULSE OXIMETER
K875298 · Criticare Systems, Inc. · Mar 1988