Cleared Traditional

K090599 - MD300K1 PULSE OXIMETER

K090599 is an FDA 510(k) clearance for MD300K1 PULSE OXIMETER, manufactured by Beijing Choice Electronic Technololgy Co., Ltd.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 137-day FDA review.

K090599 · Beijing Choice Electronic Technololgy Co., Ltd. · Anesthesiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
137d
Days
Class 2
Risk

K090599 is an FDA 510(k) clearance for the MD300K1 PULSE OXIMETER. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Beijing Choice Electronic Technololgy Co., Ltd. (Shijingshan District, Beijing, CN). The FDA issued a Cleared decision on July 20, 2009 after a review of 137 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. 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 Beijing Choice Electronic Technololgy Co., Ltd. devices

FDA 510(k) Submission Details - K090599

510(k) Number K090599 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2009
Decision Date July 20, 2009
Days to Decision 137 days
Submission Type Traditional
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
3d faster than avg
Panel avg: 140d · This submission: 137d
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 612
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K090599.
DISPOSABLE SPO2 SENSOR M1134A
K091572 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Sep 2009
CABLE, TRANSDUCER, MODEL 2400GN
K083448 · Conmed Corporation · Aug 2009
MASIMO SET REUSABLE SOFT OXIMETRY SENSORS - ADULT / PEDICATRICS, MODEL DBI/ DBIP
K090662 · Masimo Corporation · Aug 2009
RAINBOW RESPOSABLE PULSE CO-OXIMETER SENSORS, MODELS R2C-25, R2-25, R2C-20 AND R2-20
K090165 · Masimo Corporation · Jul 2009
MASIMO RAINBOW SET PRONTO PULSE CO-OXIMETER AND ACCESSORIES
K091057 · Masimo Corporation · Jul 2009
SHENZHEN MED-LINKET ADULT FINGER CLIP SPO2 SENSOR, SHENZHEN MED-LINKET ADULT SILICONE SOFT TIP SPO2 SENSOR
K083010 · Shenzhen Med-Link Electronics Tech Co., Ltd. · Jun 2009