Cleared Traditional

K160499 - Apnea Risk Evaluation System (ARES), Model 620

K160499 is an FDA 510(k) clearance for Apnea Risk Evaluation System (ARES), manufactured by Watermark Medical. The device is a Class 2 Anesthesiology device with product code MNR cleared through the Traditional 510(k) pathway after a 426-day FDA review.

K160499 · Watermark Medical · Anesthesiology device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2017
Decision
426d
Days
Class 2
Risk

K160499 is an FDA 510(k) clearance for the Apnea Risk Evaluation System (ARES), Model 620. Classified as Ventilatory Effort Recorder (product code MNR), Class II - Special Controls.

Submitted by Watermark Medical (West Palm Beach, US). The FDA issued a Cleared decision on April 24, 2017 after a review of 426 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Anesthesiology FDA review panel, regulated under 21 CFR 868.2375 - 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Anesthesiology submissions.

FDA 510(k) Submission Details - K160499

510(k) Number K160499 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2016
Decision Date April 24, 2017
Days to Decision 426 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
286d slower than avg
Panel avg: 140d · This submission: 426d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MNR Device Classification - Class 2, Special Controls

Product Code MNR Ventilatory Effort Recorder
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 868.2375
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 Consultant

Michael Leigh
Michael Leigh

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - MNR Ventilatory Effort Recorder

All 164
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K160499 · Apnea Risk Evaluation System (ARES), Model 620
Download PDF FDA Summary Watermark Medical