Cleared Traditional

K032831 - PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200

K032831 is an FDA 510(k) clearance for PRO 2 MONITOR, manufactured by Conmed Corporation. The device is a Class 2 Anesthesiology device with product code DQA cleared through the Traditional 510(k) pathway after a 355-day FDA review.

K032831 · Conmed Corporation · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2004
Decision
355d
Days
Class 2
Risk

K032831 is an FDA 510(k) clearance for the PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 2.... Classified as Oximeter (product code DQA), Class II - Special Controls.

Submitted by Conmed Corporation (Utica, US). The FDA issued a Cleared decision on August 31, 2004 after a review of 355 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the Anesthesiology review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K032831

510(k) Number K032831 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 11, 2003
Decision Date August 31, 2004
Days to Decision 355 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
215d slower than avg
Panel avg: 140d · This submission: 355d
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 726
Devices cleared under the same product code (DQA) and FDA review panel - the closest regulatory comparables to K032831.
MEDIAID REUSABLE FINGER CLIP SPO2 SENSORS AND DISPOSABLE NON-ADHESIVE SENSORS AND ADHESIVE SPO2 SENSORS
K041964 · Mediaid, Inc. · Sep 2004
PULSEOX 5500 FINGER DEVICE, PULSEOX 7500 WRISTWATCH DEVICE
K040178 · S.P.O. Medical Equipment, Ltd. · Sep 2004
FLEXI-STAT REUSABLE FINGER CLIP SPO2 SENSORS (NELLCOR-COMPATIBLE),(BCI-COMPATIBLE), (DATEX-COMPATIBLE)
K041647 · Elekon Industries U.S.A., Inc. · Sep 2004
DOLPHIN MEDICAL DOLPHIN ONE ADULT REUSABLE FOREHEAD SENSOR, MODEL 420
K040380 · Dolphin Medical, Inc. · Aug 2004
TIDAL WAVE SP MODEL 710/715 AND 715
K032971 · Respironics Novametrix, Inc. · Aug 2004
SPOT CHECK PULSE OXIMETER,512/513
K032949 · Respironics Novametrix, Inc. · Aug 2004
K032831 · PRO 2 MONITOR, PRO 2 SENSOR, PRO2 HOLDER, PRO2 NEONATE HOLDER, MODELS, PRO- 200, ANS-200, AHL-200, NHL-200
Download PDF FDA Summary Conmed Corporation