Cleared Special

K001995 - SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER

K001995 is an FDA 510(k) clearance for SPIROXCARD DIAGNOSTIC SPIROMETER AND PU..., manufactured by Qrs Diagnostic, LLC. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 70-day FDA review.

K001995 · Qrs Diagnostic, LLC · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2000
Decision
70d
Days
Class 2
Risk

K001995 is an FDA 510(k) clearance for the SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Qrs Diagnostic, LLC (Plymouth, US). The FDA issued a Cleared decision on September 8, 2000 after a review of 70 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.

FDA 510(k) Submission Details - K001995

510(k) Number K001995 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 30, 2000
Decision Date September 08, 2000
Days to Decision 70 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
70d faster than avg
Panel avg: 140d · This submission: 70d
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 702
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K001995.
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K002751 · Masimo Corp. · Oct 2000
ADULT/PEDIATRIC CEREBRAL OXIMETER, MODEL INVOS 5100
K001842 · Somanetics Corp. · Sep 2000
MODIFICATION TO MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K002682 · Masimo Corp. · Sep 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES
K002477 · Masimo Corp. · Sep 2000
MASIMO SET RADICAL PULSE OXIMETER WITH SATSHARE AND LNOP SERIES OF SENSORS AND CABLES, MODEL RADICAL, LNOP-ADT, LNOP-PDT
K002574 · Masimo Corp. · Sep 2000
MINOLTA PULSOX-3/MINOLTA PULSOX-3I
K984570 · In-X Corp. · Aug 2000
K001995 · SPIROXCARD DIAGNOSTIC SPIROMETER AND PULSE OXIMETER
Download PDF FDA Summary Qrs Diagnostic, LLC