Cleared Special

K112804 - FINGERTIP PULSE OXIMETER

K112804 is an FDA 510(k) clearance for FINGERTIP PULSE OXIMETER, manufactured by Guangdong Biolight Meditech Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Special 510(k) pathway after a 122-day FDA review.

K112804 · Guangdong Biolight Meditech Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2012
Decision
122d
Days
Class 2
Risk

K112804 is an FDA 510(k) clearance for the FINGERTIP PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Guangdong Biolight Meditech Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on January 27, 2012 after a review of 122 days - within the typical 510(k) review window.

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. Standard predicate reliance. 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 - K112804

510(k) Number K112804 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 27, 2011
Decision Date January 27, 2012
Days to Decision 122 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
18d faster than avg
Panel avg: 140d · This submission: 122d
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 726
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K112804.
PULSE OXIMETER
K112843 · Nonin Medical, Inc. · Apr 2012
PULTOL
K113865 · Sharp Corporation · Mar 2012
MASIMO SET REUSABLE OXIMETRY SENSORS
K113596 · Masimo Corporation · Feb 2012
HANDHELD PULSE OXIMETER
K111494 · Beijing Choice Electronic Technololgy Co., Ltd. · Jan 2012
MASIMO RAINBOW SET PRONTO-7 PULSE CO-OXIMETER AND ACCESSORIES
K111403 · Masimo Corporation · Dec 2011
PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1
K111617 · Acare Technology Co., Ltd. · Dec 2011
K112804 · FINGERTIP PULSE OXIMETER
Download PDF FDA Summary Guangdong Biolight Me…