Cleared Traditional

K111617 - PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1

K111617 is an FDA 510(k) clearance for PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1, manufactured by Acare Technology Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K111617 · Acare Technology Co., Ltd. · Anesthesiology device
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Dec 2011
Decision
195d
Days
Class 2
Risk

K111617 is an FDA 510(k) clearance for the PULSE OXIMETER MODEL AB-F1/AH-S1/AH-M1. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Acare Technology Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on December 22, 2011 after a review of 195 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

View all Acare Technology Co., Ltd. devices

FDA 510(k) Submission Details - K111617

510(k) Number K111617 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 10, 2011
Decision Date December 22, 2011
Days to Decision 195 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
55d slower than avg
Panel avg: 140d · This submission: 195d
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 478
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K111617.
FINGERTIP PULSE OXIMETER
K112804 · Guangdong Biolight Meditech Co., Ltd. · Jan 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
VTRUST FINGER TYPE PULSE OXIMETER
K110893 · Taidoc Technology Corporation · Nov 2011
MASIMO RESPOSABLE SPO2 SERIES OXIMETRY SENSORS, MASIMO LNCS / M-LNCS OXIMETRY SENSORS
K111621 · Masimo Corporation · Oct 2011
MASIMO LNOP/LNCS/M-LNCS MULTISITE-L OXIMETRY SENSORS
K111888 · Masimo Corporation · Sep 2011