510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K012003Substantially Equivalent

Drg Reaction Chamber/safety Tip

Doctor'S Research Group, Inc., Wolcott CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K012003 is the FDA 510(k) clearance record for DRG REACTION CHAMBER/SAFETY TIP, a class II device, cleared for Doctor'S Research Group, Inc. on under FDA product code HEI (Monitor, Heart-Valve Movement, Fetal, Ultrasonic). FDA records list 14 510(k) clearances for Doctor'S Research Group, Inc., from to . As of , FDA records show no recalls naming K012003.

Clearance record

Decision date
Received
(230 days to decision)
Product code
HEI Monitor, Heart-Valve Movement, Fetal, Ultrasonic
Regulation
21 CFR 884.2660
Device class
Class II
Review panel
Obstetrics/Gynecology
Applicant
Doctor'S Research Group, Inc. 143 Wolcott Rd., Wolcott CT
510(k) summary
Summary
Third party review
No

Clearances, product code HEI

Trailing 12 months

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

FDA records show no clearances under product code HEI in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code HEI, 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