Cleared Traditional

K881883 - SATLITE+/PB251+ PULSE OXIMETER

K881883 is an FDA 510(k) clearance for SATLITE+/PB251+ PULSE OXIMETER, manufactured by Datex Division Instrumentarium Corp.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 75-day FDA review.

K881883 · Datex Division Instrumentarium Corp. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1988
Decision
75d
Days
Class 2
Risk

K881883 is an FDA 510(k) clearance for the SATLITE+/PB251+ PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Datex Division Instrumentarium Corp. (Helsinki, Finland, FI). The FDA issued a Cleared decision on July 18, 1988 after a review of 75 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 Datex Division Instrumentarium Corp. devices

FDA 510(k) Submission Details - K881883

510(k) Number K881883 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 04, 1988
Decision Date July 18, 1988
Days to Decision 75 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
65d faster than avg
Panel avg: 140d · This submission: 75d
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 K881883.
MRL OXIMETER
K882664 · Medical Research Laboratories, Inc. · Sep 1988
HORIZON 2000 PULSE OXIMETRY AND MODULE
K882273 · Mennen Medical, Inc. · Aug 1988
EDENTEC MODEL 2800/2801 OXIMETER/PULSE OXIMETER
K881820 · Edentec 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
DINAMAP VITAL SIGNS MONITOR/PULSE OXIMETER
K874442 · Critikon Company, LLC · Feb 1988