Cleared Traditional

K053130 - ONYX II FINGER PULSE OXIMETER

K053130 is an FDA 510(k) clearance for ONYX II FINGER PULSE OXIMETER, manufactured by Nonin Medical, Inc.. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 64-day FDA review.

K053130 · Nonin Medical, Inc. · Anesthesiology device
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Jan 2006
Decision
64d
Days
Class 2
Risk

K053130 is an FDA 510(k) clearance for the ONYX II FINGER PULSE OXIMETER, MODEL 9550. Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Nonin Medical, Inc. (Plymouth, US). The FDA issued a Cleared decision on January 11, 2006 after a review of 64 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. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Nonin Medical, Inc. devices

FDA 510(k) Submission Details - K053130

510(k) Number K053130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 08, 2005
Decision Date January 11, 2006
Days to Decision 64 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
76d faster than avg
Panel avg: 140d · This submission: 64d
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 453
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K053130.
CONMED PRO2 PULSE REFLECTANCE OXIMETER, MODEL PRO-M
K061112 · Conmed Corporation · May 2006
PM-50 PULSE OXIMETER
K052693 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2006
MASIMO SET RAD 57 CM AND M PULSE CO-OXIMETERS
K053477 · Masimo Corporation · Mar 2006
OXIMAX NEOMAX ADHESIVE FOREHEAD REFLECTANCE OXIMETRY SENSOR
K051271 · Nellcor Puritan Bennett, Inc. · Jan 2006
AVANT DIGITAL PULSE OXIMETRY SYSTEM, MODEL 4000, 4100
K052669 · Nonin Medical, Inc. · Dec 2005
ADULT CEREBRAL OXIMETER, MODEL 2040
K051257 · Cas Medical Systems, Inc. · Dec 2005