Cleared Special

K993637 - N-395 PULSE OXIMETER

K993637 is an FDA 510(k) clearance for N-395 PULSE OXIMETER, manufactured by Nellcor Puritan Bennett, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 27-day FDA review.

K993637 · Nellcor Puritan Bennett, Inc. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 1999
Decision
27d
Days
Class 2
Risk

K993637 is an FDA 510(k) clearance for the N-395 PULSE OXIMETER, WITH EXTENDED DEVICE CLAIMS. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nellcor Puritan Bennett, Inc. (Carlsbad, US). The FDA issued a Cleared decision on November 24, 1999 after a review of 27 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. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Nellcor Puritan Bennett, Inc. devices

FDA 510(k) Submission Details - K993637

510(k) Number K993637 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 28, 1999
Decision Date November 24, 1999
Days to Decision 27 days
Submission Type Special
Review Panel Anesthesiology (AN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
113d faster than avg
Panel avg: 140d · This submission: 27d
Pathway characteristics
Modification to existing cleared device.

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 K993637.
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