510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K053011Substantially Equivalent

Pro-Neo Neonatal ECG Electrode, Models Sg15 and Sr20

Bio Protech, Inc., Crofton MD / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K053011 is the FDA 510(k) clearance record for PRO-NEO NEONATAL ECG ELECTRODE, MODELS SG15 AND SR20, a class II device, cleared for Bio Protech, Inc. on under FDA product code DRX (Electrode, Electrocardiograph). FDA records list 17 510(k) clearances for Bio Protech, Inc., from to . As of , FDA records show no recalls naming K053011.

Clearance record

Decision date
Received
(49 days to decision)
Product code
DRX Electrode, Electrocardiograph
Regulation
21 CFR 870.2360
Device class
Class II
Review panel
Cardiovascular
Applicant
Bio Protech, Inc. 1676 Village Green Suite A, Crofton MD
510(k) summary
Summary PDF
Third party review
No

Clearances, product code DRX

Trailing 12 months

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

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