510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K870058Substantially Equivalent

Pie Medical Scanner 1000

Pie Data Medical BV, Maastricht 6227 Aj, NL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K870058 is the FDA 510(k) clearance record for PIE MEDICAL SCANNER 1000, a class II device, cleared for Pie Data Medical BV on under FDA product code KNG (Monitor, Ultrasonic, Fetal). FDA records list 5 510(k) clearances for Pie Data Medical BV, from to . As of , FDA records show no recalls naming K870058.

Clearance record

Decision date
Received
(391 days to decision)
Product code
KNG Monitor, Ultrasonic, Fetal
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Pie Data Medical BV Philipsweg 1, Maastricht 6227 Aj, NL
Third party review
No

Clearances, product code KNG

Trailing 12 months
1 clearance under product code KNG in the twelve months to October 2026, January 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code KNG, trailing twelve months
MonthClearances
November 20250
December 20250
January 20261
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260