Cleared Traditional

K213344 - BTL-899A

K213344 is the FDA 510(k) clearance for BTL-899A by BTL Industries, Inc.. It is a Class 2 General & Plastic Surgery device (product code GEI) cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K213344 · BTL Industries, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2022
Decision
90d
Days
Class 2
Risk

K213344 is an FDA 510(k) clearance for the BTL-899A. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by BTL Industries, Inc. (Marlborough, US). The FDA issued a Cleared decision on January 5, 2022 after a review of 90 days - within the typical 510(k) review window.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery 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 & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all BTL Industries, Inc. devices

Submission Details

510(k) Number K213344 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 07, 2021
Decision Date January 05, 2022
Days to Decision 90 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
25d faster than avg
Panel avg: 115d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
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 & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1136
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K213344.
ShinEvac Smoke Evacuation Pencil
K213317 · Shining World Health Care Co., Ltd. · Jan 2022
ETHICON Megadyne Electrosurgical Generator
K213696 · Megadyne Medical Products, Inc. · Jan 2022
Medline Universal Grounding Pad
K212093 · Medline Industries, Inc. · Jan 2022
Olympus PK Electrosurgical Instruments, PK J-hook, PK Spatula, PK Needle
K213831 · Gyrus Acmi, Inc. · Jan 2022
Single Use Electrosurgical Knife with Fluid Pump System
K211172 · Micro-Tech (Nanjing) Co., Ltd. · Dec 2021
Voyant Fine Fusion Device (EB230)
K202818 · Applied Medical · Dec 2021