Cleared Traditional

K863784 - NELLCOR N-200 (PULSE OXIMETER)

K863784 is an FDA 510(k) clearance for NELLCOR N-200 (PULSE OXIMETER), manufactured by Nellcor, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K863784 · Nellcor, Inc. · Anesthesiology device
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Nov 1986
Decision
56d
Days
Class 2
Risk

K863784 is an FDA 510(k) clearance for the NELLCOR N-200 (PULSE OXIMETER). Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nellcor, Inc. (Hayward, US). The FDA issued a Cleared decision on November 21, 1986 after a review of 56 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 Nellcor, Inc. devices

FDA 510(k) Submission Details - K863784

510(k) Number K863784 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 26, 1986
Decision Date November 21, 1986
Days to Decision 56 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
84d faster than avg
Panel avg: 140d · This submission: 56d
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 K863784.
MINOLTA/MARQUEST PULSOX-7 OXYGEN SATURATION MONIT.
K863918 · Marquest Medical Products, Inc. · Jan 1987
ACCUSAT
K863855 · Datascope Corp. · Jan 1987
NELLCOR MVP, MODEL N-1000
K862812 · Nellcor, Inc. · Dec 1986
BIOCHEM CO/OX 1000
K863186 · Biochem International, Inc. · Nov 1986
SENSORMEDICS OXYSHUTTLE(TM)
K862617 · Sensor Medics Corp. · Sep 1986
MODEL 8604 OXYGEN/PULSE MONITOR
K860051 · Nonin Medical, Inc. · Jun 1986