Cleared Traditional

K896629 - NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR

K896629 is an FDA 510(k) clearance for NELLCOR MODEL N-2500 ANESTHESIA SAFETY ..., manufactured by Nellcor, Inc.. The device is a Class 2 Anesthesiology device with product code CBS cleared through the Traditional 510(k) pathway after a 82-day FDA review.

K896629 · Nellcor, Inc. · Anesthesiology device
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Feb 1990
Decision
82d
Days
Class 2
Risk

K896629 is an FDA 510(k) clearance for the NELLCOR MODEL N-2500 ANESTHESIA SAFETY MONITOR. Classified as Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.) (product code CBS), Class II - Special Controls.

Submitted by Nellcor, Inc. (Hayward, US). The FDA issued a Cleared decision on February 12, 1990 after a review of 82 days - a notably fast clearance cycle.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.1620 - 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 - K896629

510(k) Number K896629 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 22, 1989
Decision Date February 12, 1990
Days to Decision 82 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
58d faster than avg
Panel avg: 140d · This submission: 82d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

CBS Device Classification - Class 2, Special Controls

Product Code CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.1620
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 - CBS Analyzer, Gas, Halothane, Gaseous-phase (anesthetic Conc.)

All 12
Devices cleared under the same product code (CBS) and FDA review panel - the closest regulatory comparables to K896629.
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