510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K023713Substantially Equivalent

Sonoprep Impedance Diagnostics (Idx) System, Model D1000

Sontra Medical, Inc., Cambridge MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K023713 is the FDA 510(k) clearance record for SONOPREP IMPEDANCE DIAGNOSTICS (IDX) SYSTEM, MODEL D1000, a class II device, cleared for Sontra Medical, Inc. on under FDA product code KRC (Tester, Electrode, Surface, Electrocardiographic). FDA records list 2 510(k) clearances for Sontra Medical, Inc., from to . As of , FDA records show no recalls naming K023713.

Clearance record

Decision date
Received
(450 days to decision)
Product code
KRC Tester, Electrode, Surface, Electrocardiographic
Regulation
21 CFR 870.2370
Device class
Class II
Review panel
Cardiovascular
Applicant
Sontra Medical, Inc. 58 Charles St., Cambridge MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code KRC

Trailing 12 months

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

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