510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K191407Substantially Equivalent

Novalung System

Fresenius Medical Care Renal Therapies Group, LLC, Waltham MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K191407 is the FDA 510(k) clearance record for Novalung System, a class II device, cleared for Fresenius Medical Care Renal Therapies Group, LLC on under FDA product code QJZ (Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure). FDA's definition for product code QJZ reads: "Extracorporeal circuit and accessories for long-term respiratory/cardiopulmonary failure". FDA records list 95 510(k) clearances for Fresenius Medical Care Renal Therapies Group, LLC, from to . As of , FDA records show 2 recalls naming K191407.

Clearance record

Decision date
Received
(269 days to decision)
Product code
QJZ Extracorporeal System For Long-Term Respiratory / Cardiopulmonary Failure
Regulation
21 CFR 870.4100
Device class
Class II
Review panel
Cardiovascular
Applicant
Fresenius Medical Care Renal Therapies Group, LLC 920 Winter St., Waltham MA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QJZ

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