510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K083693Substantially Equivalent

Pb 840 Ventilator System with Leak Compensation Option, Model 840

Covidien, Formerly Nellcor Puritan Bennett, Inc., Carlsbad CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K083693 is the FDA 510(k) clearance record for PB 840 VENTILATOR SYSTEM WITH LEAK COMPENSATION OPTION, MODEL 840, a class II device, cleared for Covidien, Formerly Nellcor Puritan Bennett, Inc. on under FDA product code CBK (Ventilator, Continuous, Facility Use). FDA records list 5 510(k) clearances for Covidien, Formerly Nellcor Puritan Bennett, Inc., from to . As of , FDA records show no recalls naming K083693.

Clearance record

Decision date
Received
(111 days to decision)
Product code
CBK Ventilator, Continuous, Facility Use
Regulation
21 CFR 868.5895
Device class
Class II
Review panel
Anesthesiology
Applicant
Covidien, Formerly Nellcor Puritan Bennett, Inc. 2101 Faraday Ave., Carlsbad CA
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