Cleared Traditional

K913695 - NELLCOR(R) N-180 PULSE OXIMETER

K913695 is an FDA 510(k) clearance for NELLCOR N-180 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 86-day FDA review.

K913695 · Nellcor, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1991
Decision
86d
Days
Class 2
Risk

K913695 is an FDA 510(k) clearance for the NELLCOR(R) N-180 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 13, 1991 after a review of 86 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 - K913695

510(k) Number K913695 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 19, 1991
Decision Date November 13, 1991
Days to Decision 86 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
54d faster than avg
Panel avg: 140d · This submission: 86d
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 K913695.
NOVAMETRIX MODEL 7100 COMB. END TIDAL CO2 & PUL OX
K920379 · Novametrix Medical Systems, Inc. · Jul 1992
SENSORMEDICS OXYSHUTTLE II(TM)
K913790 · Sensor Medics Corp. · Feb 1992
VITALMAX 510/520
K912880 · Pace Tech, Inc. · Nov 1991
MODEL 520A NOVAMETRIX PULSE OXIMETER
K913516 · Novametrix Medical Systems, Inc. · Nov 1991
SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION
K911761 · S & W Medico Teknik · Oct 1991
CIBA CORNING MODEL 270 CO-OXIMETER
K913332 · Ciba Corning Diagnostics Corp. · Oct 1991