Cleared Traditional

K890033 - MODEL 8700 PULSE OXIMETER

K890033 is an FDA 510(k) clearance for MODEL 8700 PULSE OXIMETER, manufactured by Nonin Medical, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 33-day FDA review.

K890033 · Nonin Medical, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Feb 1989
Decision
33d
Days
Class 2
Risk

K890033 is an FDA 510(k) clearance for the MODEL 8700 PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nonin Medical, Inc. (Minneapolis, US). The FDA issued a Cleared decision on February 6, 1989 after a review of 33 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 Nonin Medical, Inc. devices

FDA 510(k) Submission Details - K890033

510(k) Number K890033 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 04, 1989
Decision Date February 06, 1989
Days to Decision 33 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
107d faster than avg
Panel avg: 140d · This submission: 33d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K890033.
KONTRON PULSE OXIMETER 7840
K890299 · Kontron Instruments, Inc. · Mar 1989
CNS-8200A CENTRAL NURSES STATION
K884050 · Nihon Kohden America, Inc. · Feb 1989
AL-800PA PULSE OXIMETER MODULE
K884536 · Nihon Kohden America, 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