Cleared Traditional

K213068 - Medline Smoke Evacuation Shroud

K213068 is an FDA 510(k) clearance for Medline Smoke Evacuation Shroud, manufactured by Medline Industries, Inc.. The device is a Class 2 General Hospital device with product code FYD cleared through the Traditional 510(k) pathway after a 102-day FDA review.

K213068 · Medline Industries, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
102d
Days
Class 2
Risk

K213068 is an FDA 510(k) clearance for the Medline Smoke Evacuation Shroud. Classified as Apparatus, Exhaust, Surgical (product code FYD), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Cleared decision on January 3, 2022 after a review of 102 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Medline Industries, Inc. devices

FDA 510(k) Submission Details - K213068

510(k) Number K213068 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 23, 2021
Decision Date January 03, 2022
Days to Decision 102 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 129d · This submission: 102d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

FYD Device Classification - Class 2, Special Controls

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 Peers - FYD Apparatus, Exhaust, Surgical

All 46
Devices cleared under the same product code (FYD) and FDA review panel - the closest regulatory comparables to K213068.
PlumeSafe X5 Smoke Management System
K240127 · Conmed Corporation · Aug 2024
8Q10 Surclear Smoke Plume Evacuation System
K233789 · Surnic Corporation · Apr 2024
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
EvaQMax Smoke Evacuation System
K192035 · Bio Protech, Inc. · Aug 2019
Megadyne Foot Switch
K191328 · Megadyne Medical Products, Inc. · Jul 2019