510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K193056Substantially Equivalent

Puritan Bennett 980 Series Ventilator System

Medtronic, Inc., Boulder CO / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K193056 is the FDA 510(k) clearance record for Puritan Bennett 980 Series Ventilator System, a class II device, cleared for Covidien, LLC on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 1,525 510(k) clearances for Medtronic, Inc., from to . As of , FDA records show 17 recalls naming K193056.

Clearance record

Decision date
Received
(385 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Covidien, LLC 6135 Gunbarrel Ave., Boulder CO
510(k) summary
Summary PDF
Third party review
No

Clearances, product code CBK

Trailing 12 months
4 clearances under product code CBK in the twelve months to October 2026, December 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code CBK, trailing twelve months
MonthClearances
November 20250
December 20251
January 20260
February 20260
March 20261
April 20261
May 20261
June 20260
July 20260
August 20260
September 20260
October 20260