Cleared Traditional

K250429 - DSPS-Prominent® baseplate, MR (113820) (FDA 510(k) Clearance)

Also includes:
DSPS-Prominent® baseplate (113120) DSPS-Prominent® Cradle-I (113140) DSPS-Prominent® Cradle-II (113150) DSPS-Prominent® Cradle-III (113160) DSPS-Prominent® Cradle-IV (113170) DSPS-Prominent® Cradle-VI (113180) DSPS-Prominent® Cradle-VII (113260) Mask DSPS®-PROSCVRL set/5 (113760) Mask DSPS®-PROSC set/5 (113770) Mask DSPS®-PROSCVR set/5 (113780) Mask DSPS®-PROSCL set/5 (113790) Mask DSPS®-PROSHVRL set/5 (113890) Mask DSPS®-PROSH set

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

K250429 · Macromedics BV · Radiology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Mar 2025
Decision
33d
Days
Class 2
Risk

K250429 is an FDA 510(k) clearance for the DSPS-Prominent® baseplate, MR (113820). Classified as Accelerator, Linear, Medical (product code IYE), Class II - Special Controls.

Submitted by Macromedics BV (Moordrecht, NL). The FDA issued a Cleared decision on March 19, 2025 after a review of 33 days - a notably fast clearance cycle.

This device falls under the Radiology FDA review panel, regulated under 21 CFR 892.5050 - the FDA radiology and imaging software oversight 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 Macromedics BV devices

Submission Details

510(k) Number K250429 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2025
Decision Date March 19, 2025
Days to Decision 33 days
Submission Type Traditional
Review Panel Radiology (RA)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
74d faster than avg
Panel avg: 107d · This submission: 33d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code IYE Accelerator, Linear, Medical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 892.5050
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 Radiology devices follow this clearance model.

Regulatory Peers - IYE Accelerator, Linear, Medical

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