Cleared Traditional

EvaQMax Smoke Evacuation System (K192035) - FDA 510(k) Clearance

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K192035 · Bio Protech, Inc. · General Hospital
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Aug 2019
Decision
30d
Days
Class 2
Risk

K192035 is an FDA 510(k) clearance for the EvaQMax Smoke Evacuation System. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Bio Protech, Inc. (Wonju-Si, KR). The FDA issued a Cleared decision on August 29, 2019 after a review of 30 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.5070 - the FDA general hospital 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 Bio Protech, Inc. devices

Submission Details

510(k) Number K192035 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 30, 2019
Decision Date August 29, 2019
Days to Decision 30 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
99d faster than avg
Panel avg: 129d · This submission: 30d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

Device Classification

Product Code FYD Apparatus, Exhaust, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.5070
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 General Hospital devices follow this clearance model.

Regulatory Consultant

Regulatory Technology Services, LLC
Prithul Bom

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 - FYD Apparatus, Exhaust, Surgical

All 74
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K192035.
PlumeSafe X5 Smoke Management System
K240127 · Conmed Corporation · Aug 2024
8Q10 Surclear Smoke Plume Evacuation System
K233789 · Surnic Corporation · Apr 2024
Medline Smoke Evacuation Shroud
K213068 · Medline Industries, Inc. · Jan 2022
NEBULAE SRS Laparoscopic Surgical Smoke Removal System
K202944 · Northgate Technologies, Inc. · Mar 2021
Megadyne Smoke Evacuator, Megadyne Filter, Megadyne Fluid Trap, Megadyne Connect Cable, 1 m and 2.1 m, Megadyne RF Sensor
K200250 · Megadyne Medical Products, Inc. · Jun 2020
Megadyne Foot Switch
K191328 · Megadyne Medical Products, Inc. · Jul 2019

Related FDA 510(k) Regulatory Insights

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.