Cleared Traditional

K250795 - PUREVUE™ FMS

K250795 is an FDA 510(k) clearance for PUREVUE FMS, manufactured by W.O.M. World of Medicine GmbH. The device is a Class 2 Orthopedic device with product code HRX cleared through the Traditional 510(k) pathway after a 266-day FDA review.

K250795 · W.O.M. World of Medicine GmbH · Orthopedic device
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Dec 2025
Decision
266d
Days
Class 2
Risk

K250795 is an FDA 510(k) clearance for the PUREVUE™ FMS. Classified as Arthroscope (product code HRX), Class II - Special Controls.

Submitted by W.O.M. World of Medicine GmbH (Berlin, DE). The FDA issued a Cleared decision on December 5, 2025 after a review of 266 days - an extended review cycle.

This device falls under the Orthopedic FDA review panel, regulated under 21 CFR 888.1100 - the FDA orthopedic device regulatory 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 Orthopedic review framework, consistent with the majority of Class II 510(k) submissions.

View all W.O.M. World of Medicine GmbH devices

FDA 510(k) Submission Details - K250795

510(k) Number K250795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 14, 2025
Decision Date December 05, 2025
Days to Decision 266 days
Submission Type Traditional
Review Panel Orthopedic (OR)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
144d slower than avg
Panel avg: 122d · This submission: 266d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HRX Device Classification - Class 2, Special Controls

Product Code HRX Arthroscope
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 888.1100
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 Orthopedic devices follow this clearance model.

Regulatory Peers - HRX Arthroscope

All 523
Devices cleared under the same product code (HRX) and FDA review panel - the closest regulatory comparables to K250795.
Freedom DS™ Decompression System
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