510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K901033Substantially Equivalent

Mer Multiplane Rectal Probe (Mrp)

Medical Equipment Resources, San Leandro CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K901033 is the FDA 510(k) clearance record for MER MULTIPLANE RECTAL PROBE (MRP), a class II device, cleared for Medical Equipment Resources on under FDA product code IYO (System, Imaging, Pulsed Echo, Ultrasonic). FDA records list 2 510(k) clearances for Medical Equipment Resources. As of , FDA records show no recalls naming K901033.

Clearance record

Decision date
Received
(169 days to decision)
Product code
IYO System, Imaging, Pulsed Echo, Ultrasonic
Regulation
21 CFR 892.1560
Device class
Class II
Review panel
Radiology
Applicant
Medical Equipment Resources 16303 Panoramic Way, San Leandro CA
Third party review
No

Clearances, product code IYO

Trailing 12 months
8 clearances under product code IYO in the twelve months to October 2026, February 2026 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code IYO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20262
March 20261
April 20262
May 20260
June 20261
July 20261
August 20260
September 20261
October 20260