510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191912Substantially Equivalent

BiWaze Cough

Abmrc, LLC, Charleston SC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191912 is the FDA 510(k) clearance record for BiWaze Cough, a class II device, cleared for Abmrc, LLC on under FDA product code NHJ (Device, Positive Pressure Breathing, Intermittent). FDA records list one 510(k) clearance for Abmrc, LLC. As of , FDA records show no recalls naming K191912.

Clearance record

Decision date
Received
(254 days to decision)
Product code
NHJ Device, Positive Pressure Breathing, Intermittent
Regulation
21 CFR 868.5905
Device class
Class II
Review panel
Anesthesiology
Applicant
Abmrc, LLC 239, Fair Child St., Daniel Island, Charleston SC
510(k) summary
Summary PDF
Third party review
No

Clearances, product code NHJ

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