Cleared Traditional

K250309 - BTL-199 (FDA 510(k) Clearance)

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

K250309 · BTL Industries, Inc. · Physical Medicine device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2025
Decision
185d
Days
Class 2
Risk

K250309 is an FDA 510(k) clearance for the BTL-199. Classified as Electromagnetic Stimulator, Pain Relief (product code QPL), Class II - Special Controls.

Submitted by BTL Industries, Inc. (Marlborough, US). The FDA issued a Cleared decision on August 7, 2025 after a review of 185 days - an extended review cycle.

This device falls under the Physical Medicine FDA review panel, regulated under 21 CFR 882.5890 - the FDA physical medicine 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 Physical Medicine review framework, consistent with the majority of Class II 510(k) submissions.

View all BTL Industries, Inc. devices

Submission Details

510(k) Number K250309 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 03, 2025
Decision Date August 07, 2025
Days to Decision 185 days
Submission Type Traditional
Review Panel Physical Medicine (PM)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 115d · This submission: 185d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code QPL Electromagnetic Stimulator, Pain Relief
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5890
Definition Intended To Apply A Magnetic-field Induced Electrical Current To Treat Pain.
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 Physical Medicine devices follow this clearance model.

Regulatory Peers - QPL Electromagnetic Stimulator, Pain Relief

Devices cleared under the same product code (QPL) and FDA review panel - the closest regulatory comparables to K250309.
Rapid2 Magnetic Stimulators (Magstim Rapid2, Magstim Super Rapid2, Magstim Super Rapid2 Plus1)
K250286 · The Magstim Company Limited · Jul 2025
StarFormer (M008-3T)
K241785 · Fotona D.O.O. · Mar 2025
Axon Therapy
K233364 · Neuralace Medical, Inc. · Jan 2024
MagVenture Pain Therapy: MagPro R30, MagPro R30 with MagOption, MagPro X100, MagPro X100 with MagOption
K230014 · Tonica Elektronik A/S · Aug 2023