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
K900271Substantially Equivalent

Model Ob-500 Fetal Growth Analysis & Option Oblink

Digisonics, Inc, Houston TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K900271 is the FDA 510(k) clearance record for MODEL OB-500 FETAL GROWTH ANALYSIS & OPTION OBLINK, a class II device, cleared for Digisonics, Inc. on under FDA product code HEM (Imager, Ultrasonic Obstetric-Gynecologic). FDA records list 3 510(k) clearances for Digisonics, Inc., from to . As of , FDA records show no recalls naming K900271.

Clearance record

Decision date
Received
(90 days to decision)
Product code
HEM Imager, Ultrasonic Obstetric-Gynecologic
Regulation
21 CFR 884.2225
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Digisonics, Inc. 2401 Portsmouth, Houston TX
Third party review
No

Clearances, product code HEM

Trailing 12 months

FDA records hold no clearances under product code HEM in the trailing twelve months.

FDA records show no clearances under product code HEM in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HEM, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260